BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASK

    MDR report key: 11648018 · Received April 9, 2021

    Report

    Report Number
    MW5100679
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    May 1, 2020
    Report Date
    April 7, 2021
    Manufacturer
    UNK
    Product Code
    QKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WORE A MASK TO THE STORE AND STARTED TO GET DIZZY AND FAINTED. THIS HAPPENED TO ME THREE TIMES IN (B)(6) 2020. I CANNOT WEAR A MASK OR A BANDANNA. THIS IS INHUMANE. COTTON BANDANNA. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541533 MASK FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention