BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTECH FACEMASK BLUE EARLOOP LEVEL 2 MASKS

    MDR report key: 22863724 · Received August 21, 2025

    Report

    Report Number
    MW5175106
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    August 5, 2025
    Report Date
    August 14, 2025
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    SERVICE PERSONNEL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THE DISTECH FACEMASK BLUE EARLOOP LEVEL 2 MASKS BREAK HER OUT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 10/8/2025 FOR REPORT MW5175106 TO CORRECT MANUFACTURER AND FOI ADDRESS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189750 DISTECH FACEMASK BLUE EARLOOP LEVEL 2 MASKS MASK, SURGICAL FXX AMD MEDICOM INC. 13410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown