BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASK

    MDR report key: 10655465 · Received October 9, 2020

    Report

    Report Number
    10655465
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    August 2, 2020
    Report Date
    September 23, 2020
    Manufacturer
    DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD
    Product Code
    MSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MASKS WERE FOUND TO HAVE BROKEN EAR LOOPS. QTY OF 5 FROM A NEW BOX WHEN IT WAS OPENED. SENDING THE PRODUCT TO VENDOR/REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118678 MASK RESPIRATOR, SURGICAL MSH DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD 20040703060 20040703060

    Patients

    Seq Age Sex Outcome Treatment
    1