BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FACE MASKS - FDA EMERGENCY USE AUTHORIZED

    MDR report key: 11796763 · Received May 7, 2021

    Report

    Report Number
    MW5101243
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 5, 2021
    Manufacturer
    UNK
    Product Code
    QKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TRIGGERS MIGRAINE; EVERY DAY I HAVE TO WEAR THE FACE MASK MEDICAL DEVICE UNDER EUA, I GET AN EXCRUCIATING MIGRAINE AFTER APPROXIMATELY 30 MIN. ADDITIONALLY, I AM HEARING IMPAIRED AND EVERYONE ELSE WEARING FACE MASKS MAKES IT VIRTUALLY IMPOSSIBLE FOR ME TO ENGAGE IN REASONABLE PUBLIC SETTINGS BECAUSE I NEED TO SEE PEOPLE¿S MOUTHS TO HEAR/ UNDERSTAND WHAT THEY ARE SAYING. THE FORCED ISOLATION THE MASKS CAUSE ME IS BECOMING UNBEARABLE. THE HUMAN CONDITION INCLUDES OUR EXPOSED FACES TO BE HEALTHY AND CONNECT WITH OTHERS. WE ARE NOT DESIGNED TO LIVE IN ISOLATION AND DEVOID OF FACIAL EXPRESSION. ALL FACE COVERINGS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684822 FACE MASKS - FDA EMERGENCY USE AUTHORIZED FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other