MAUDE Adverse Event Report: AMD MEDICOM INC. MEDICOM SAFEMASK MASTER SERIES L3

Model Number	2058
Health Effect - Clinical Codes	Dyspnea (1816); Rash (2033)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is in progress.
Event or Problem Description
The following incident was reported to amd medicom on september 24, 2020 for medicom safemask master series l3 item 2085: "during general dental duties roughly 6 staff members were all experiencing some type of reaction from these masks.Most experienced a rash on their face on the bottom part of their chin as well as near their mouth while one of the staff members as they were breathing in felt that the fibers inside the mask gave her shortness of breath, making it hard to breathe.She went to the hospital where she was given benadryl and was monitored.The same day she went back to work.Once all stopped wearing the rash had cleared.No staff specifics were provided and as they have already sent back using label that was provided, they could not provide the lot number of the masks.This was the first time using these types of masks".
Event or Problem Description
The following incident was reported to amd medicom on 24-sep-2020 for medicom safemask master series l3 item 2085: "during general dental duties roughly 6 staff members were all experiencing some type of reaction from these masks.Most experienced a rash on their face on the bottom part of their chin as well as near their mouth while one of the staff members as they were breathing in felt that the fibers inside the mask gave her shortness of breath, making it hard to breathe.She went to the hospital where she was given benadryl and was monitored.The same day she went back to work.Once all stopped wearing the rash had cleared.No staff specifics were provided and as they have already sent back using label that was provided, they could not provide the lot number of the masks.This was the first time using these types of masks.".
Additional Manufacturer Narrative
The investigation shows that if the rolls of raw material are left uncovered, they can come in contact with dust.Dust and debris could cause the skin irritation (rashes).The handling of material to machines by forklift drivers was checked, the material specification sheet has been verified as well.It was noticed that some material were uncovered and exposed to dust and debris returned samples were evaluated.No visual defects were observed.Also, the returned masks were worn for a period of time (single use not for long time or the whole day), no skin problem happened.The root cause has not been identified.The wearing of a single mask for a long period could cause the fibers to break down and detach from the mask, which can cause the irritation.Corrective actions: on a daily basis, material handlers and warehouse personnel will perform checks to make sure that the raw material is entirely covered with no holes in the wrappers when stored in the warehouse/staging areas.Any material with holes in the wrappers will be automatically disqualified from use in the production.Operators will make sure that the material is covered when out on the floor, and maintenance /warehouse staff will start stretch wrapping used rolls before taking them back to the warehouse.

• Brand Name: MEDICOM SAFEMASK MASTER SERIES L3
• Common Device Name: MASK
• Manufacturer (Section D): AMD MEDICOM INC.; 2555 chemin de l'aviation; pointe-claire, quebec, canada H9P 2 Z2; CA H9P 2Z2
• MDR Report Key: 10730882
• Report Number: 9611959-2020-00004
• Device Sequence Number: 3450833
• Product Code: FXX
• UDI-Device Identifier: 10686864047671
• UDI-Public: 10686864047671
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K051291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2058
• Device Catalogue Number: 2058
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other