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

Catalog Number	570-2047
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Asthma (1726); Itching Sensation (1943); Rash (2033)
Date of Event	09/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 40 year old female dentist had a mild skin irritation and rash on her face after wearing the masks as well as have an asthma attack.The duration of the symptoms were for two days until she noticed the correlation to the masks.She needed to take abuterol to help and has since gotten better.
Additional Manufacturer Narrative
On september 19, 2023, amd medicom inc.Received the event that a dentist had a mild skin irritation after using the henry schein maxima earloop masks.On september 27, 2023 additional information was received indicating that the dentist had a rash on her face and had an asthma attack and needed to take albuterol as a result.An investigation is in progress.
Additional Manufacturer Narrative
On september 19, 2023, amd medicom inc.Received the event that a dentist had a mild skin irritation after using the henry schein maxima earloop masks.On september 27, 2023 additional information was received indicating that the dentist had a rash on her face and had an asthma attack and needed to take albuterol as a result.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 tot he mask being cytotoxic, skin irritant or skin sensitizer.The batch records and design history file were verified and no abnormality was noted.In addition, testing was performed on the returned samples where a blind test was conducted (i.E.Returned samples worn by individuals blinded to the samples).The blind test concluded that none of the participants felt itchy or uncomfortable following wearing the masks after 8 hours.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
A 40 year old female dentist had a mild skin irritation and rash on her face after wearing the masks as well as have an asthma attack.The duration of the symptoms were for two days unitl she noticed the correlation to the masks.She needed to take abuterol to help and has since gotten better.

• Brand Name: HENRY SCHEIN
• Common Device Name: MAXIMA 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.; no.11, sec2, ligong 1st rd; wujie township yilan, taiwan 26841 ; TW 26841
• MDR Report Key: 17890350
• Report Number: 9611959-2023-00001
• Device Sequence Number: 15341339
• Product Code: FXX
• UDI-Device Identifier: 10304040138912
• UDI-Public: (01)10304040138912
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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: Health Professional
• Device Catalogue Number: 570-2047
• Device Lot Number: T2303
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 12/12/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female