MAUDE Adverse Event Report: AMD MEDICOM INC. HENRY SCHEIN CRITERION EARLOOP MASK L1; EARLOOP FACE MASK

Model Number	104-3809
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation ongoing.
Event or Problem Description
The 41-year-old female doctor states they developed a rash on their face after using the mask.They went to a dermatologist for follow up.No other information is available.
Event or Problem Description
The 41-year-old female doctor states they developed a rash on their face after using the mask.They went to a dermatologist for follow up.No other information is available.
Additional Manufacturer Narrative
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, retained and returned samples, device master record and design history file were verified and no observations were noted.Based on the investigation, no root cause was identified.

• Brand Name: HENRY SCHEIN CRITERION EARLOOP MASK L1
• 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): MEDICOM ASIA-PACIFIC HOLDINGS LIMITED.; no.11, sec2, ligong 1st rd; wujie township yilan, taiwan 26841 ; TW 26841
• MDR Report Key: 20878122
• Report Number: 9611959-2024-00004
• Device Sequence Number: 7683627
• Product Code: FXX
• UDI-Device Identifier: 00304040019283
• UDI-Public: 00304040019283
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 104-3809
• Device Lot Number: T2307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Age: 41 YR
• Patient Sex: Female