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ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator - recalled due to defective applicator, USA

April 20, 2021 8:00 PM

United States

Company name: Becton, Dickinson and Company
Brand name: ChloraPrep
Product recalled: ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator
Reason of the recall: Defective applicator
FDA Recall date: April 20, 2021
Recall details: BD (Becton, Dickinson and Company), a leading global medical technology company, is voluntarily recalling specified lots of the ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator (2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) to the user level due to a defective applicator. The product is used as an antiseptic for the preparation of the patient's skin prior to surgery to help reduce bacteria that potentially can cause skin infection.

The ChloraPrep™ 26 mL Applicator contains glass ampules that house the sterile ChloraPrep™ solution. In normal circumstances, the product is activated by squeezing the wing on the applicator to break the ampule, which releases the solution to the sponge head for application to the patient’s skin. In certain lots, the applicator end cap was improperly secured due to a manufacturing error.

This can result in broken glass and solution dropping out of the applicator once activated. In some cases, the glass ampules can drop out before activation and shatter if striking a hard surface, resulting in solution and glass fragments scattering in the procedure area and potentially causing injury to patients and health care professionals.
These products were distributed in the United States and Puerto Rico.

BD Risk Assessment: Immediate health consequences could be lacerations to patient and/or user of the device.  It is possible that these could range from superficial to deep lacerations.  While BD has no current reports of severe injury, it is possible that lacerations could cause damage to structures such as nerves or tendons, however, this is considered unlikely.

Long-term health consequences could include superficial or deep lacerations that could lead to infection and scarring. “Flying” glass shards could potentially cause injury to the patient or user, including eye injuries. Splashing ChloraPrep™ solution could contact the eyes of the user or patient. If tissues or organs other than the skin and subcutaneous tissues are damaged, permanent impairment could occur. While blood loss could accompany these injuries, it would be readily controllable with simple standard measures.

To date, BD has received 56 complaints with only one laceration injury reported with respect to this issue. As part of the voluntary recall to the user level, the company is notifying customers and distributors affected by the recall. BD’s Customer Recall Notification provides instructions to customers and distributors for disposal and replacement of the impacted ChloraPrep™ 26 mL Applicator (see list of affected lot numbers in the link below).

Customer inquiries related to this recall, as well as adverse reaction/events experienced with the product should be addressed to BD Customer Support at 1-844-8BD- LIFE (1-844-823-5433); When calling Monday- Friday between the hours of 9 a.m. to 6 p.m. ET, say “Recall” when prompted. For additional information, customers can visit www.bd-chloraprep-action.comExternal Link Disclaimer. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

The U.S. Food and Drug Administration (FDA) has been notified of this recall.

Check the full recall details on fda.gov

Source: FDA

Reported By SafelyHQ.com User
More incidents from:
Recall
Medical Devices
United States

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May 10, 2021 4:00 PM

“Company name: Novo Nordisk
Brand name: Levemir, Tresiba, Fiasp, Novolog and Xultophy
Product recalled: Product Samples
Reason of the recall: Due to improper storage temperature conditions
FDA Recall date: May 10, 2021
Recall details: Novo Nordisk is voluntarily recalling 1,468 product samples... See Morelisted in the table below of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy®, to the consumer level. These products are being recalled because they were stored at temperatures below storage requirements.

This recall only impacts product samples and does not impact product that has been broadly distributed to pharmacies or mail-order services. If product samples are exposed to temperatures below 32°F, it could cause a lack of efficacy and damage to the cartridge and pen-injectors. If product from an improperly stored vial, cartridge or pen-injector is used, there is a risk that you might not receive the right amount of medicine as intended which may lead to hyperglycemia or hypoglycemia resulting in adverse health consequences ranging from limited to life-threatening.

Novo Nordisk has not received any reports of serious adverse events or injuries related to this recall. These products are used to lower blood glucose levels in people with diabetes and are packaged in cartons with either a vial, pen-injector (FlexPen® or FlexTouch®) or a cartridge (PenFill®). A list of the affected lots can be found in the link below.

The product can be identified by looking for the batch number or lot number located on the product or carton and matching it to the list above. Novo Nordisk has notified all physician offices that received affected samples and requested all impacted samples be returned. Customers who received an affected sample through the physician’s office should have received a letter from their physician.

If product samples match a batch number or there are any questions about the recall, please contact the Novo Nordisk recall processor Inmar at 1-888-686-5002, Monday through Friday, 9:00 AM to 5:00 PM EDT. Please report any complaints and adverse events to Novo Nordisk's Customer Care Center which can be reached at 1-800-727-6500, Monday through Friday, 8:30 AM to 6:00 PM EDT.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

May 11, 2021 11:00 AM

“Company name: Yamtun7
Brand name: Poseidon
Product recalled: Male Sexual Enhancement Dietary Supplement
Reason of the recall: Undeclared Tadalafil and Sildenafil
FDA Recall date: May 11, 2021
Recall details: Delray Beach, Florida, Yamtun7 is voluntarily recalling all lots of Poseidon Platinu... See Morem 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil and sildenafil. Tadalafil and sildenafil are drugs known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of tadalafil and sildenafil in Poseidon Platinum 3500 makes it an unapproved new drug for which the safety and efficacy have not been established and, therefore subject to recall.

Consumers with underlying medical issues who take Poseidon Platinum 3500 with undeclared tadalafil and sildenafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Yamtun7 has not received any reports of adverse events related to this recall. This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in a blue pack which contains one single blue pill with blue label and gold text with barcode 0 95842 05876 0. The affected lot numbers include all lots. Poseidon Platinum 3500 was distributed via internet and by eBay at www.ebay.com/usr/yamtun7store from July 1, 2019 to September 28, 2020 to nationwide in the USA.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Yamtun7 is notifying its customers by this press announcement and via e-mail of this recall.

Consumers that have Poseidon Platinum 3500, which is being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Yamtun7 by phone at 561-674-3203 7 days of week from 9 am to 5 pm EDT or e-mail yamtun7@gmail.com. Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online. Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

May 11, 2021 3:01 PM

“Company name: Dash Xclusive
Brand name: Imperia Elita
Product recalled: Vitaccino Coffee weight loss and anxiety dietary supplement
Reason of the recall: Undeclared Sibutramine and Fluoxetine
FDA Recall date: May 11, 2021
Recall details: Glendale, California, Dash Xclusive is voluntarily recal... See Moreling all lots of Imperia Elita Vitaccino Coffee to the consumer level. FDA analysis has found the product to contain undeclared sibutramine and fluoxetine. Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues, including stroke, heart failure and serious health risk especially to those with underlying heart related disease.

Fluoxetine is an FDA approved drug indicated for the treatment of various depressive disorders, obsessive compulsive disorder, bulimia and panic disorders. This drug product carries a box warning for suicidal thoughts and behaviors and it needs to be monitored closely by a prescriber. The presence of sibutramine and fluoxetine in Imperia Elita Vitaccino coffee renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to a recall. Dash Xclusive has not received any reports of adverse events related to this recall.

Risk Statement: Products containing undeclared sibutramine pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Products containing undeclared fluoxetine could cause suicidal thinking and behavior, an accumulation of high levels of serotonin in the body or neuroleptic malignant syndrome (NMS)-like reactions which is a life-threatening neurological disorder; elevated mood state that can cause higher than normal energy levels, restlessness, decreased need for sleep; abnormal bleeding, and low sodium levels.

The product is marketed  as a dietary supplement for weight loss and is packaged in a black rectangular box and contains fifteen sachets. The affected Imperia Elita Vitaccino coffee lots include all lots. Product was distributed Nationwide in the USA via internet and by ebay at www.ebay.com. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Dash Xclusive is notifying its customers by e-messages on the eBay platform and is arranging for return of all recalled products. Consumers that have Imperia Elita Vitaccino Coffee which is being recalled should stop using/return to Dash Xclusive, 610 S. Verdugo Road, Apt 31, Glendale, California 91205. Consumers with questions regarding this recall can contact Dash Xclusive by e-mail at dashxclusive11@gmail.com on Mondays to Thursdays from 11am to 4pm Pacific Time zone. 

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or by fax. Complete and submit the report Online. Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

May 12, 2021 8:00 PM

“Company name: Dibar Nutricional S. de R.L. de C.V.
Brand name: DIBAR Labs, ProtectoRx
Product recalled: Hand Sanitizer
Reason of the recall: Presence of methanol
FDA Recall date: May 12, 2021
Recall details: Company Announcement Morelia, Michoacán, Mexico, Dibar Nutricional S. de R.L. De C.V. (... See More“Dibar”) is voluntarily recalling 27 lots of DIBAR Labs Hand Sanitizer packaged in 8oz (8-53090-00301-3 UPC) and 16 oz (8-53090-00302-0 UPC) fluid ounce bottles, respectively, to the consumer level. (See products listed in the link below in Table 1 and Label 1). Dibar is also voluntarily recalling 2 lots of ProtectoRx Hand Sanitizer packaged in 2oz (Lot Number LDHSN050720) and 16oz (Lot Number LDHSN050820) fluid ounce bottles, respectively, to the consumer level. (See products listed in the link below in Table 2 and Label 2). These products are being recalled after testing conducted by our firm revealed the presence of methanol. 

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest the products and adolescents and adults who drink the products as an alcohol (ethanol) substitute are most at risk for methanol poisoning.

To date, the company has not received any reports of adverse reactions related to this recall. These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. The affected bottles of hand sanitizer include a twelvedigit lot code printed on the bottle near the base.

The products can be identified by the label, scent, and lot code provided in the table at the end of this release. These products were distributed nationwide in the USA through S.E.N.D. LLC and its customers (Click in the link below Table 1). Products labeled as ProtectoRx Hand Sanitizer were distributed in Puerto Rico through PR TRADING LLC and its customers (Click in the link below Table 2.). Dibar Nutricional S. de R.L. De C.V., has notified its direct distributors by a letter with confirmatory email and asked that they remove the recalled products from commerce immediately if they still had any in inventory. Consumers, distributors and retailers that have the hand sanitizers which are being recalled should stop using, distributing and/or selling them and return them to the place of purchase.

Consumers with questions regarding this recall can contact our Commercial Offices, +52 443-314-5369, M-F, during business hours 9:00 a.m. – 6:00 p.m. ET and/or email us to QA@dibarlabs.com.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or by fax.

- Complete and submit the report Online.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. (Table 1. Lots distributed to S.E.N.D. LLC and its customers)  

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

May 13, 2021 2:01 PM

“Company name: Global Sanitizers
Brand name: Medically Minded
Product recalled: Hand Sanitizer
Reason of the recall: Presence of methanol
FDA Recall date: May 13, 2021
Recall details: Las Vegas, NV, Global Sanitizers is voluntarily recalling 50 thousand units of Medically Minded hand sanitizers,... See Morelot numbers: E212020 & E082020 Best Buy of 5/21/2022 to the user/consumer level. FDA analysis has found the product to contain methanol.

Risk Statement: Substantial methanol exposure can result in coma, seizures, permanent blindness, permanent damage to the central nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date, Global Sanitizers has not received any reports of adverse events related to this recall. These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. Medically Minded hand sanitizer is packaged in 8.5 oz / 250 ml clear bottles with caps with the following UPC 7675300359. The affected Medically Minded hand sanitizer lots include the following lot numbers and expiration dates E212020 & E082020 Best Buy of 5/21/2022. The product can be identified by the representative label below.

The hand sanitizer was distributed Nationwide in the USA to Wholesale companies who further distributed between July 2020 -August 2020. Global Sanitizers is notifying its distributors and customers by Email, Letter, Telephone & Press Release and is arranging for return of all recalled products. Consumers/distributors/retailers that have Medically Minded hand sanitizer product which is being recalled should stop using/return to place of purchase/discard/contact their doctor.

Consumers with questions regarding this recall can contact Global Sanitizers by calling 702.323.4402 or e-mail address recall@globalsanitizers.com Monday through Friday 9am-5pm pacific standard time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.  

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

May 13, 2021 3:03 PM

“Company name: Scentsational Soaps & Candles, Inc.
Brand name: Goose Creek, COCO TKO
Product recalled: Hand Sanitizer
Reason of the recall: Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde
FDA Recall date: May 13, 2021
Recall details: Scentsational Soaps & Candles, Inc., has volunta... See Morerily expanded its April 27 recall of scented Hand Sanitizers to include three lots of Goose Creek HAND SANITIZER (NDC 75078-004) + Aloe and one lot of COCO TKO HAND SANITIZER in 3.38 and 3.4 fluid ounce spray bottles, respectively, to the consumer level.

These products are listed in the table below. These products are being recalled after testing conducted by our firm revealed the presence of methanol (wood alcohol), benzene, and acetaldehyde. These products were sold on the Internet and distributed nationwide in the USA by Goose Creek Candles, LLC and Coconut Stand.

- Goose Creek HAND SANITZER + Aloe Goose (3.38 fl oz. (100 ml)). Scent: Blueberry Limeade Anti-Bacterial Spray. UPC or NDC: NO UPC. Lot: 20258. Retailer and States shipped: 36 cases shipped on 9/22/20 to KY.
- Goose Creek HAND SANITIZER + Aloe (3.38 fl oz. (100 ml)). Scent: Limoncello Anti-Bacterial Spray. UPC or NDC: NO UPC. Lot: 20258. Retailer and States shipped: 36 cases shipped on 9/22/20 to KY.
- Goose Creek HAND SANITIZER + Aloe Goose (3.38 fl oz. (100 ml)). Scent: Beach Dreams Anti-Bacterial Spray. UPC or NDC: No UPC. Lot: 20258. Retailer and States shipped: 36 cases shipped on 9/22/20 to KY.
- Goose Creek HAND SANITIZER + Aloe Goose (3.38 fl oz. (100 ml)). Scent: Grape Soda Anti-Bacterial Spray. UPC or NDC: No UPC. Lot: 20258. Retailer and States shipped: 36 cases shipped on 9/22/20 to KY.
- Goose Creek HAND SANITIZER + Aloe Goose (3.38 fl oz. (100 ml)). Scent: Champagne Bubbles Anti-Bacterial Spray. UPC or NDC: No UPC. Lot: 20258. Retailer and States shipped: 36 cases shipped on 9/22/20 to KY.
- Goose Creek HAND SANITIZER + Aloe Goose (3.38 fl oz. (100 ml)). Scent: Dragonfruit Splash Anti-Bacterial Spray. UPC or NDC: No UPC. Lot: 20258. Retailer and States shipped: 36 cases shipped on 9/22/20 to KY.
- Goose Creek HAND SANITIZER + Aloe Goose (3.38 fl oz. (100 ml)). Scent: Marshmallows Anti-Bacterial Spray. UPC or NDC: No UPC. Lot: 20258. Retailer and States shipped: 36 cases shipped on 9/22/20 to KY.
- Goose Creek HAND SANITIZER + Aloe Goose (3.38 fl oz. (100 ml)). Scent: Melon Picnic Anti-Bacterial Spray. UPC or NDC: No UPC. Lot: 20259. Retailer and States shipped: 35 cases shipped on 9/22/20 to KY.
- Goose Creek HAND SANITIZER + Aloe Goose (3.38 fl oz. (100 ml)). Scent: Optimistic Vibes Anti-Bacterial Spray. UPC or NDC: No UPC. Lot: 20259. Retailer and States shipped: 36 cases shipped on 9/22/20 to KY.
- Goose Creek HAND SANITIZER + Aloe Goose (3.38 fl oz. (100 ml)). Scent: Red White and Blue Anti-Bacterial Spray. UPC or NDC: No UPC. Lot: 20259. Retailer and States shipped: 42 cases shipped on 9/22/20 to KY.
- Goose Creek HAND SANITIZER + Aloe Goose (3.38 fl oz. (100 ml)). Scent: Watermelon Lemonade Anti-Bacterial Spray. UPC or NDC: No UPC. Lot: 20259. Retailer and States shipped: 35 cases shipped on 9/22/20 to KY.
- Goose Creek HAND SANITIZER + Aloe Goose (3.38 fl oz. (100 ml)). Scent: Tropical Daydream Anti-Bacterial Spray. UPC or NDC: No UPC. Lot: 20260. Retailer and States shipped: 36 cases shipped on 9/22/20 to KY.
- COCO TKO HAND SANITIZER (3.4 fl oz. (100.55 ml)). Scent: Coconut Stand. UPC or NDC: No UPC. Lot: 20260. Retailer and States shipped: 14 cases shipped on 9/16/20 to FL.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest the products and adolescents and adults who drink the products as an alcohol (ethanol) substitute are most at risk for methanol poisoning. Exposure to benzene can occur through inhalation, oral, and skin.

There is a reasonable probability that benzene present at levels above the maximum daily exposure recommendations can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening. Additionally, animal studies have shown that acetaldehyde can possibly cause cancer in humans. To date, the company has not received any reports of adverse reactions related to this recall.

These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. The affected bottles of hand sanitizer include a five-digit lot code printed on the bottle near the base. The products can be identified by the label, scent, and lot code provided in the table at the end of this release. Photos are also provided at www.scentsational-products.com.

Scentsational Soaps & Candles, Inc. has notified its direct customers by telephone with confirmatory email and asked that they remove the recalled products from commerce immediately if they still had any in inventory. Consumers, distributors, and retailers that have the hand sanitizers which are being recalled should stop using, distributing and/or selling them and return them to the place of purchase.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

May 13, 2021 11:25 PM

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“Company name: Dibar Nutricional S. de R.L. de C.V.
Brand name: DIBAR Labs, ProtectoRx
Product recalled: Hand Sanitizer
Reason of the recall: Presence of methanol
FDA Recall date: May 12, 2021
Recall details: Company Announcement Morelia, Michoacán, Mexico, Dibar Nutricional S. de R.L. De C.V. (... See More“Dibar”) is voluntarily recalling 27 lots of DIBAR Labs Hand Sanitizer packaged in 8oz (8-53090-00301-3 UPC) and 16 oz (8-53090-00302-0 UPC) fluid ounce bottles, respectively, to the consumer level. (See products listed in the link below in Table 1 and Label 1). Dibar is also voluntarily recalling 2 lots of ProtectoRx Hand Sanitizer packaged in 2oz (Lot Number LDHSN050720) and 16oz (Lot Number LDHSN050820) fluid ounce bottles, respectively, to the consumer level. (See products listed in the link below in Table 2 and Label 2). These products are being recalled after testing conducted by our firm revealed the presence of methanol. 

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest the products and adolescents and adults who drink the products as an alcohol (ethanol) substitute are most at risk for methanol poisoning.

To date, the company has not received any reports of adverse reactions related to this recall. These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. The affected bottles of hand sanitizer include a twelvedigit lot code printed on the bottle near the base.

The products can be identified by the label, scent, and lot code provided in the table at the end of this release. These products were distributed nationwide in the USA through S.E.N.D. LLC and its customers (Click in the link below Table 1). Products labeled as ProtectoRx Hand Sanitizer were distributed in Puerto Rico through PR TRADING LLC and its customers (Click in the link below Table 2.). Dibar Nutricional S. de R.L. De C.V., has notified its direct distributors by a letter with confirmatory email and asked that they remove the recalled products from commerce immediately if they still had any in inventory. Consumers, distributors and retailers that have the hand sanitizers which are being recalled should stop using, distributing and/or selling them and return them to the place of purchase.

Consumers with questions regarding this recall can contact our Commercial Offices, +52 443-314-5369, M-F, during business hours 9:00 a.m. – 6:00 p.m. ET and/or email us to QA@dibarlabs.com.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or by fax.

- Complete and submit the report Online.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. (Table 1. Lots distributed to S.E.N.D. LLC and its customers)  

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

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“I have 2 sick, A week and a half ago Née bag of Kibbles and bits bistro and the Melody Just started about a week and a half ago now I have two dogs sick one with an IV in the hospital See Less
Reported By SafelyHQ.com User
Doctor Visit: Yes
Diagnosis: Hospital

LONG TERM continued extreme immune response to Pfizer vaccine, Danville, PA, USA

Symptoms: Fever Other Chills Chest Pain Swelling
Danville, PA, USA

May 12, 2021 5:59 PM

“I am going to post my entire diary. Those who truly want to know won't mind reading the entire thing and...it's still not over yet.

Pfizer 51 day systemic reaction
(now beyond day 77)
Danville, PA


*Not a complaint*
(wasn't at the time)

I had left prior short term reviews on both do... See Moreses, now I am finally able to detail my entire reaction which was shocking to me honestly. Arthritis/fibro/immune compromised patients be advised.

After dose 1 on 3 Mar, it simply made my left hand ballooned then arthritic (never had arthritic hands before this) and it seemed as if it was going to relent, but kept coming and going, then eventually this spread to both hands and ankles. I gained 3 pounds of water weight. The pain was maddening from day 8 on, coming and going.

Day 12 I had routine nonsteroidal spinal injections. MISTAKE. I wouldn't advise doing this but it was urgent as I needed the injections to have the capability to drive to dose 2. My whole left side's injection sites swelled and scabbed over several days. (never had that happen in 12 years of receiving them) I could not sit down, lie down, or touch the sites but it resolved quickly in my opinion. The hand pain stayed the course until...

Dose 2 I was thankful to receive and looked forward to my newfound freedom. 1 Apr I had the minor eye floaters on the way home just like dose 1. I felt like a dead dog so fell asleep on the couch as soon as I walked through the door. 7 hours later developed chills and mild fever and leg (quads) pain. No big deal I thought as this happens to everyone. I began consuming electrolytes and rode the fever out with the aid of Ibuprofen. My last review ended with me saying I expect a 1 to 2 day recovery. That is not what really happened.

Following dose 2 ( lot # EP7534) I suffered an entire body inflammatory response.
The leg pain became so severe I had difficulty walking or doing anything at all for 8 days. Any attempt at physical activity doubled the pain. This is when I had my first Dr appointment and I was told to be patient and it should resolve in 2 to 4 WEEKS, and if not I need to be tested for Rheumatoid. I waited patiently and prayed for this to end. As a former athlete, I will admit to being way less sore after running a marathon.

The legs began to ease up but it traveled back to my hands, then to my lower back, then to my knees and feet. Called our Covid hotline at least 4 times during the 3 week course of this barrage and was told that this kind of reaction is almost unheard of. It then hit my hips. This was so excruciating for a week I had to lift my legs by hand to get up, and once again I could walk but didn't desire to. Next doctor appointment, was advised if the pain will not resolve in a timely manner, I need a full examination and bloodwork for gout and 7 other tests were ordered.

While laid up, incidentally my Father received dose 1 of Moderna. He was symptom free until Day 8, then, had the exact same reaction but on a lesser scale. It was then I started to believe something in our genetics is causing it. Day 52, it FINALLY began subsiding. The swelling reduced and became localized to the right knee (prior injury) and the left hand.

Overall, this was a severe reaction but I do not solely blame the vaccine. I am a 43 year old woman with Fibromyalgia and a slew of other compromising health issues. These companies did their ultimate best to save lives, perhaps mine included. Although devastated to seemingly have permanent damage to the knuckles of my left hand, tissue of the right knee and knuckles of my foot, there has been far greater devastation from Covid, including losing a family member.

I am extremely hesitant towards the booster, but I need the protection to feel at peace with sending my children back to school. I will follow my doctor's advice and the Covid team's direction to fill out the VAERS surveys for both doses. This information is found in small print on the back of the card.

*CONTINUED*

It did NOT end here either. 48 hours after the joint pain "subsided," I went to bed thinking it was all over then woke up in Tachycardia shortly after midnight with a heart rate of 156! ? For 3 days I had my daughter sleep in my bed with me as I battled a severely irregular heart beat. This was preposterous as I spent decades as a personal trainer and thought (knew!) I had a very healthy heart?

On the 3rd day of being stuck in chronic tachycardia episodes, my daughters ended up urgently calling family and an ambulance because I felt symptoms of a possible stroke.

In the ambulance my BP had escalated to 167/110 and normal for me is actually always quite low. In fact I had a reading of 117/74 the week prior during an unrelated visit. I have never had a high blood pressure reading in my entire life not from any illness or activity ever!

At the hospital I was informed my kidneys had astonishingly dropped to less than 40% of function and I was in real trouble. They stabilized me and sent me home, then a day later I went right back into tachycardia for an additional 3 days. I did the equivalent of a marathon or more each night IN MY SLEEP. I was given a heart monitor to record the activity and set up with an urgent echocardiogram and CT of my heart. With a blood clotting disorder, I could not afford to mess around any longer and had to leave my kids once again to be driven to the ER. 7 additional hours I spent with a pulse often above 150. I was finally given a Beta blocker and also an antibiotic, as the dehydration this was causing me erupted into a kidney infection which was throbbing on my right side.

I feared for me life. I feared for my vitality as my Pain treatments were stripped away due to the suspected heart condition. All my heart tests came back completely normal and I was told my heart is oddly not the source of my heart condition. A relief yes, but just further proof of how extremely and completely this vaccine attacked my body.

I was having chest pains the week prior and the week of these attacks which was finally concluded to be new Costochondritis, a rare flareup which can happen with Fibromyalgia. Thank God that's all it is but I am so through with this vaccine now and the utter devastation it has caused my entire body. I am having trouble breathing and the umpteen hospital visits have ruled out everything else. It is not anxiety but I will admit alas I have begun to grow impatient with this!! I have 1/2 dozen medical professionals in contact with me daily now working on a way to get me to the finish line.

After clearing my heart tests, I was reinstated for Pain Management and was brought in immediately for an appointment. My back underwent approximately 30 trigger point injections and there was not a location on my body without a muscle spasm. My last injections were rejected by my body due to the presence of the vaccine and I prayed this time they wouldn't be. During the procedure I suffered an immediate inflammatory response, elevated blood pressure, etc etc. My skin reacted so badly my administrator could not even apply the bandages. 13 years getting these injections and no problems until right now!

Next day it started happening all over again. My body (more specifically, the vaccine within my body) began to reject some of my treatment in the lower region. I am now being put on a steroid to combat the vaccine and widespread pain reaction of the chest, legs, hips, extremities, and back. I continue to take the Beta blocker now as well.

10 weeks of suffering I just want it to end but more importantly I have to stay vigilant in getting my story told. I'm willing to bet a reaction like this will turn out not to be so rare. In fact my Father is still laid up just the same as me he's in week 5 battling Moderna and also on a long road. My final report to the CDC will be submitted after further bloodwork, but it is to be made absolutely clear that if I have now developed an auto-immune condition...the vaccine triggered it.

Good luck to everyone but honestly weigh the decision heavily before you enter the unknown.
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Reported By SafelyHQ.com User
Doctor Visit: Yes
Diagnosis: ER

April 29, 2021 10:25 AM

““I purchased this Stihl chain saw on Feb 4, 2021 from Blackcass but to date all I received was a chain with grips. I would like my saw as ordered or a full refund and they pay for shipping. See Less
Reported By SafelyHQ.com User

May 11, 2021 3:01 PM

“Company name: Dash Xclusive
Brand name: Imperia Elita
Product recalled: Vitaccino Coffee weight loss and anxiety dietary supplement
Reason of the recall: Undeclared Sibutramine and Fluoxetine
FDA Recall date: May 11, 2021
Recall details: Glendale, California, Dash Xclusive is voluntarily recal... See Moreling all lots of Imperia Elita Vitaccino Coffee to the consumer level. FDA analysis has found the product to contain undeclared sibutramine and fluoxetine. Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues, including stroke, heart failure and serious health risk especially to those with underlying heart related disease.

Fluoxetine is an FDA approved drug indicated for the treatment of various depressive disorders, obsessive compulsive disorder, bulimia and panic disorders. This drug product carries a box warning for suicidal thoughts and behaviors and it needs to be monitored closely by a prescriber. The presence of sibutramine and fluoxetine in Imperia Elita Vitaccino coffee renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to a recall. Dash Xclusive has not received any reports of adverse events related to this recall.

Risk Statement: Products containing undeclared sibutramine pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Products containing undeclared fluoxetine could cause suicidal thinking and behavior, an accumulation of high levels of serotonin in the body or neuroleptic malignant syndrome (NMS)-like reactions which is a life-threatening neurological disorder; elevated mood state that can cause higher than normal energy levels, restlessness, decreased need for sleep; abnormal bleeding, and low sodium levels.

The product is marketed  as a dietary supplement for weight loss and is packaged in a black rectangular box and contains fifteen sachets. The affected Imperia Elita Vitaccino coffee lots include all lots. Product was distributed Nationwide in the USA via internet and by ebay at www.ebay.com. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Dash Xclusive is notifying its customers by e-messages on the eBay platform and is arranging for return of all recalled products. Consumers that have Imperia Elita Vitaccino Coffee which is being recalled should stop using/return to Dash Xclusive, 610 S. Verdugo Road, Apt 31, Glendale, California 91205. Consumers with questions regarding this recall can contact Dash Xclusive by e-mail at dashxclusive11@gmail.com on Mondays to Thursdays from 11am to 4pm Pacific Time zone. 

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or by fax. Complete and submit the report Online. Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

2nd Dose Pfizer Vaccine, Parkland Hospital, Harry Hines Boulevard, Dallas, TX, USA

Symptoms: Nausea Headache Dizziness Fatigue Body Ache Soreness
Parkland Hospital, Harry Hines Boulevard, Dallas, TX, USA

April 21, 2021 6:01 PM

“Day 1 after vaccination my symptoms were a headache, nausea, medicine head, dizzy spells and alittle fatigue. Day 2 after my second dose. My symptoms include the following, sore painful arm, nausea, slight headache, medicine head, body & muscle aches, lymph nodes appeared to be inflamed which caused... See Moremy ears to hurt. Felt like I had a mild case of the flu. Been miserable and missing 2 days of work because of this. See Less
Reported By SafelyHQ.com User

May 4, 2021 11:48 PM

“I was sent a comando chain instead this company is a fraud and PayPal let it happen 😡😡😡🤦🏽‍♀️🤬 See Less
Reported By SafelyHQ.com User