BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE FACE MASKS

    MDR report key: 11663664 · Received April 13, 2021

    Report

    Report Number
    MW5100740
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Report Date
    April 11, 2021
    Manufacturer
    UNK
    Product Code
    QKR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ALL BUSINESSES IN (B)(6) ARE REQUIRING FACE MASKS FOR ENTRY WHICH I BELIEVE ARE CATEGORIZED AS MEDICAL DEVICES. WHY??? THEY SHOULD NOT BE ALLOWED TO FORCE THIS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554980 DISPOSABLE FACE MASKS FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR