BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYD CARE FACE MASK

    MDR report key: 11568049 · Received March 24, 2021

    Report

    Report Number
    MW5100236
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    March 10, 2021
    Report Date
    March 22, 2021
    Manufacturer
    BYD PRECISION MANUFACTURE CO.,LTD.
    Product Code
    QKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS DOES NOT OCCUR ON JUST ONE PARTICULAR DATE. WEARING A FACE MASK ALL DAY AT WORK ALWAYS LEAVES ME FEELING NAUSEOUS, LIGHT HEADED AFTER ABOUT 4 HOURS. AT THE END OF THE DAY I HAVE A BAD HEADACHE THAT DOES NOT RESOLVE WITH MEDICATION. IT RESOLVES OVERNIGHT AFTER SLEEPING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456462 BYD CARE FACE MASK RESPIRATORS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY QKR BYD PRECISION MANUFACTURE CO.,LTD. FE2211 1200528

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR