BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASK

    MDR report key: 11731344 · Received April 26, 2021

    Report

    Report Number
    MW5100982
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    April 21, 2021
    Report Date
    April 22, 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

    HAD TO LEAVE JOB DUTIES; WHILE WEARING MASK AT WORK, I BECAME DIZZY AND FELT FAINT. I BELIEVE IT WAS BECAUSE I WASN'T GETTING ENOUGH OXYGEN. THIS WAS A THIRD INCIDENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618421 MASK FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK
    618422 MASK FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK
    618423 MASK FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other