MAUDE Adverse Event Report: AMD MEDICOM INC. MEDICOM SAFEMASK TAILORMADE; EARLOOP FACE MASK

Catalog Number	2072
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Two females in the office had facial swelling and breathing issues after wearing the masks.1 female had to see a physician and was placed on medication.They are still experiencing rash breakouts.
Additional Manufacturer Narrative
On april 19, 2024, amd medicom inc.Received the event that two females in the office had facial swelling and breathing issues after wearing the masks.One female had to see a physician and was placed on medication.They are still experiencing rash breakouts.
Additional Manufacturer Narrative
On april 19, 2024, amd medicom inc.Received the event that two females in the office had facial swelling and breathing issues after wearing the masks.One female had to see a physician and was placed on medication.They are still experiencing rash breakouts.Additional information: an investigation was conducted.Biocompatibility (cytotoxicity, skin irritation and skin sensitization) test results were verified on the mask constructions for this product and the results did not reveal any biological risks with respect to the mask being cytotoxic, skin irritant or skin sensitizer.Production records and design history file were verified and no observations were noted.No similar complaint was observed during historical review of complaints.Based on the investigation, no root cause was identified.Note: name/address of the manufacturing site was corrected.
Event or Problem Description
Two females in the office had facial swelling and breathing issues after wearing the masks.1 female had to see a physician and was placed on medication.They are still experiencing rash breakouts.

• Brand Name: MEDICOM SAFEMASK TAILORMADE
• Common Device Name: EARLOOP FACE MASK
• Manufacturer (Section D): AMD MEDICOM INC.; 2555 chemin de l'aviation; pointe-claire, quebec, canada H9P 2 Z2; CA H9P 2Z2
• Manufacturer (Section G): A.R. MEDICOM INC. (SHANGHAI) CO. LTD; no. 290 & 302, xiangche road; songjiang district; shanghai 20161 1; CH 201611
• MDR Report Key: 19315348
• Report Number: 9611959-2024-00001
• Device Sequence Number: 6911771
• Product Code: FXX
• UDI-Device Identifier: 10686864036415
• UDI-Public: 10686864036415
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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: Other
• Device Catalogue Number: 2072
• Device Lot Number: 3828
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female