BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FACE MASK

    MDR report key: 11607684 · Received April 1, 2021

    Report

    Report Number
    MW5100497
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    March 20, 2020
    Report Date
    March 30, 2021
    Manufacturer
    FLTR, INC.
    Product Code
    QKR
    UDI-DI
    1001214267
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ONGOING COVID MASK MANDATE AGGRAVATES MY CHRONIC MIGRAINE HEADACHES AND ASSOCIATED SYMPTOMS. UNABLE TO WEAR MASK FOR MORE THAN A FEW MINUTES BEFORE FEELING INCREASED HEAD PAIN, DIZZINESS, NAUSEA, SUFFOCATION, FAINT; CHOKING, CLOSED THROAT, BRAIN FOG, IMBALANCE WHILE WALKING, PANIC. THIS MANDATE HAS RUINED MY LIFE, I.E., CANNOT BOARD A PLANE TO SEE MY ONLY LIVING RELATIVES. HAVE TRIED MANY TYPES OF PRODUCT TO NO AVAIL. PLEASE MIGRAINEURS NEED A MEDICAL EXEMPTION FROM THIS CRUEL MANDATE. NOTE: IN (B)(6) 2019 JUST BEFORE THE SHUTDOWN/MASK MANDATE I TRAVELLED CROSS-COUNTRY ROUND TRIP ON A PACKED PLANE AND NEVER CAUGHT COVID. HAVE NOT BEEN ILL (OTHER THAN MIGRAINE) FOR DECADES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501240 FACE MASK FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR FLTR, INC. 1468552 1001214267

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability