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Guaynabo, Puerto Rico

Updated: March 10, 2021 12:00 PM
1. A lot of staff in a small place, increasing the likelihood of contagion of diseases. 2. Poor cleanliness in the area. 3. A mixture of cleaning products that could cause poisoning.

Alleged Hazards: 3, Employees Exposed: 35
Source: Osha.gov | Receipt Date: 2020-03-30 See Less
42


1. Employer allows the crowding of people on site. 2. No temperature is taken to employees or customers when entering the workplace. 3. Patron does not clean the work areas. Store Plaza del Norte

Alleged Hazards: 3, Employees Exposed: 3000
Source: Osha.gov | Receip Date: 2021-01-25 See Less
42


1. Employer continues its operations when seven (7) employees are positive to Covid-19.

Alleged Hazards: 1, Employees Exposed: 20
Source: Osha.gov | Receip Date: 2020-07-27 See Less
42


1.Employer does not have a Covid-19 Exposure Control Plan when visiting communities. 2.Lack of training employees on the Covid-19 Exposure Control Plan.

Alleged Hazards: 2, Employees Exposed: 10
Source: Osha.gov | Receip Date: 2020-07-20 See Less
42


1. Employer did not follow the COVID-19 Exposure Control Plan when employees were positive for the virus.

Alleged Hazards: 1, Employees Exposed: 30
Source: Osha.gov | Receip Date: 2020-08-13 See Less
42


Patrono no provee equipo para evitar contagio con COVID-19 (face shields o mascarilla).

Alleged Hazards: 1, Employees Exposed: 1000
Source: Osha.gov | Receipt Date: 2020-06-16 See Less
42


1.Employer does not follow protocols in its Exposure Control Plan such as social distancing and in positive cases to Covid-19. 2.Employee does not perform a screening method at the entrance of employees to the building. 3.Lack of a Blood Pathogen Program. 4.Lack of training employees on the... See More Blood Pathogens Program. Area: 2nd floor, Pediatric and adult clinic

Alleged Hazards: 4, Employees Exposed: 90
Source: Osha.gov | Receip Date: 2020-10-13
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42


It is alleged that employees (clerks and letter carriers) are exposed to the following conditions at the station: Item #1 Emergency exit door blocked with boxes and equipment Item #2 Housekeeping not performed at station (garbage/common areas) Item #3 USPS COVID19 protocol and CDC guidelines not implemented:... See More a. 50 employees working inside station in close proximity (within 1 feet of each other) b. Face masks are not worn by several employees including managers c. Work areas and surfaces are not cleaned and disinfected

Alleged Hazards: 3, Employees Exposed: 80
Source: Osha.gov | Receipt Date: 2020-07-28
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42


1- Employer does not have Self Certification. 2- Employer has not guided staff on its Covid-19 Exposure Control Plan. 3- Patron does not clean or disinfect common areas such as corridors, bathrooms and food area.

Alleged Hazards: 3, Employees Exposed: 50
Source: Osha.gov | Receip Date: 2020-09-30 See Less
42


1.Patron did not follow an Exposure Control Plan to COVID-19 when an employee was positive for the virus.
2. They don't have a continuous cleaning protocol.
3. They do not control the number of people in the property.


Alleged Hazards: 3, Employees Exposed: 50
Source: OSHA.gov |... See More Receipt Date: 2020-07-29 See Less
42


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On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or... See More the position of the implant, potentially resulting in serious injury or death. Sleepnet has been distributing masks with magnets worldwide since 2006 and to date, there have been no Medical Device Reports associated with the Sleepnet masks with magnets.

Affected products are Mojo Full Face Vented Mask, Mojo Full Face Non‐Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non‐ Vented Mask, Mojo 2 Full Face AAV Non‐Vented Mask, iQ 2 Nasal Mask, and Phantom 2 Nasal Mask. This is applicable to all lot/UDI numbers.

Sleepnet masks with magnets are safe when used in accordance with the newly updated Instructions for Use. Continue using masks according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Sleepnet is adding a new contraindication and an updated warning to the Instructions for Use labeling of the affected products. This will be included in the labeling for all future production of these masks. The labeling will be updated to state the following:
1- New Contraindication:
Do not use this mask if you or anyone (example: household members, bed partners, caregivers, etc.) in close physical contact with your mask has an active medical implant or metallic implant that will interact with magnets. Implant examples include, but are not limited to, pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, aneurysm clips, metallic stents, ocular implants, insulin/infusion pumps, cerebral spinal fluid (CSF) shunts, embolic coils, metallic splinter, implants to restore hearing or balance with implanted magnets (such as cochlear implants), flow disruption devices, contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, bone substitute device, magnetic metallic implants/electrodes/valves placed in upper limbs , torso, or higher, etc. If you have any questions regarding the implant, consult your physician or the manufacturer of your implant.

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Magnets are used in the mask and headgear clips with a field strength of 380mT. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 16 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This applies to you or anyone in close physical contact with your mask.

If a patient, or anyone in close physical contact, has an active medical implant or metallic implant, they should contact their mask supplier to find a replacement mask that does not include magnets. If the patient is unsure whether or not they should use the mask, they should consult their physician or the manufacturer of their implant.

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: Sleepnet Corporation
Brand name: Mojo, Mojo 2, iQ 2, Phantom 2
Product recalled: CPAP and BIPAP Masks with Magnets
Reason of the recall: Potential interference with certain medical implants
FDA Recall date: March 18, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sleepnet-corporation-issues-worldwide-recall-cpap-and-bipap-masks-magnets-due-potential-interference
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