Create a Report

Please provide report title
Please provide location
Please provide details

Get alerts and updates for your case!

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Skip this step

Add photos or video

We recommend photos and videos to help explain your report

Add Photo/Video
Skip this step

Email or SMS copy of report

Enter below to get emailed a copy of your report, or sms a link to your report

Please provide email or phone
Please provide email or phone

Thank you for your report!


IMPORTANT - Your report is queued
It may take up to 12 hours to process your report.


Email us at support@safelyhq.com if you have questions.

Report by

Safety Report: Megadyne Electrodes - Alert to Use for ages 12+ only, USA

3 months ago source fda.gov

Recall notice

United States

Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA SOFT pads were used. These reports of patient burn injuries described up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.

Since that notification, we have continued to monitor device performance through post market surveillance, investigated every event reported and evaluated potential root cause of these events. Megadyne recently received a report of pediatric use that included a serious 3rd degree patient burn. We are providing this additional broad public communication to increase awareness that MEGADYNE™ MEGA SOFT™ Universal and Universal Plus products should not be used for patients under the age of 12 years.

The list below contains the specific product and codes in scope.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Patient Return Electrode, Product Code: 0845, UDI-DI: 10614559103906.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Dual Patient Return Electrode, Product Code: 0846, UDI-DI: 10614559104248.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Patient Return Electrode, Product Code: 0847, UDI-DI: 10614559104842.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Dual Patient Return Electrode, Product Code: 0848, UDI-DI: 10614559104859.

Customers should review and follow the instructions provided in the December 2023 recall notification (link given below). Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes pads may continue to be used for patients over 12 years of age.

Confirm that personnel using the Mega Soft Universal and Universal Plus pads understand the intended use is changing to patients aged 12 years and older and have stopped using the pads on patients under the age of 12 years. Hospitals using this product should confirm receipt of the recall notification using the business reply form provided with the initial recall notification.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Megadyne Medical Products, Inc.
Brand name: Megadyne
Product recalled: Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes
Reason for the recall: Limit use to patients aged 12 years or older.
FDA Recall date: February 29, 2024

Recall link of December 2023: www.jnjmedtech.com/libraries/pdf.js/web/viewer.html
Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadyne-reiterates-intended-use-population-change-megadyne-mega-soft-universal-and-universal-plus

#medicaldevices #recall #us

Recent Interesting Reports

Hospira, Inc., a Pfizer company (“Pfizer”), is voluntarily recalling the lots listed in the table below of Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units to the User level. The recall was initiated due to the potential for incomplete crimp seals; one customer… See more

#recall #drugs #pfizer #us

C
I ordered 3 Hdwificampro cameras and charged me on my credit cards with shipping costs…When it arrived there’s all of them doesn’t work no matter how i tried and tried, and followed the instructions that came with it… there’s not even a contact no that I can… See more

#onlineshopping #scam #onlinescam #delivery #calgary #alberta #ca

R
I looked at the item but did not order. i want to send the item back
I would like a shipping table to send back the two pairs of shoes I got. Don't want and I didn't order them

#unorderedpackage #delivery #3646southwolcottavenue #chicago #illinois #us

M
Received a package I did not order from JERRY(001)-YASFBARA, 9208 Charles Smith Ave. RANCHO CUCAMONGA, CA 91730. Assuming they will make a fake review of an item I did not order, but not the item they sent. Cheap bracelets or hair ties. They are going in the garage.

#unorderedpackage #minneapolis #minnesota #us

Q
I ordered boots from Dallader Boots supposedly made in the USA and of good quality. Nope, and they came from Jerry(001) Yasfbara. No return address to the original shipping address and a shipping label on top of the original. I'm out $60. swapped the good boots with cheap product.

#onlineshopping #scam #delivery #onlinescam #medford #oregon #us

Z
I received 2 packages that I didn't order.... Billing my card for 2 separate transactions of $119.95 each.... Nutraition 1777 Abram CT #2021 San Leandro CA 94577 #'s used to bill to my banking account. I want that money refunded to my account asap!!!!

#ketogummiesscam #unorderedpackage #delivery #uspostalservice #lumberton #northcarolina #us

Last 30 days