MAUDE Adverse Event Report: AMD MEDICOM INC. HENRY SCHEIN MAXIMA EARLOOP MASK

Model Number	5702042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is in progress.
Event or Problem Description
An employee broke out and had trouble breathing several different times form wearing this mask.As a result the person sought medical care for this reaction.The 68 year old female clerk had redness, severe swelling and blistering on face, worse where the mask was.Her voice was hoarse and felt like their throat was closing up.
Additional Manufacturer Narrative
An investigation was conducted.Biocompatibility testing (cytotoxicity, skin irritation, skin sensitization) was reviewed and no abnormality was found.Batch records were reviewed and no abnormality was found.Complaint history was reviewed and no trend was observed.Based on the investigation, no root cause was identified.No quality issue nor defect of the functionality with the device was identified.
Event or Problem Description
An employee broke out and had trouble breathing several different times form wearing this mask.As a result the person sought medical care for this reaction.The 68 year old female clerk had redness, severe swelling and blistering on face, worse where the mask was.Her voice was hoarse and felt like their throat was closing up.

• Brand Name: HENRY SCHEIN MAXIMA EARLOOP MASK
• Common Device Name: EARLOOP 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. TAIWAN BRAN; no.11, sec2, ligong 1st rd; wujie township yilan, 26841 ; TW 26841
• Manufacturer Contact: may kansou ; 2555 chemin de l'aviation; pointe-claire, quebec H9P 2-Z2 ; CA H9P 2Z2
• MDR Report Key: 15710500
• Report Number: 9611959-2022-00001
• Device Sequence Number: 5144925
• Product Code: FXX
• UDI-Device Identifier: 10304040138882
• UDI-Public: 10304040138882
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/11/2023

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 Model Number: 5702042
• Device Catalogue Number: 570-2042
• Device Lot Number: T2201
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female