BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FACE MASK

    MDR report key: 10541012 · Received September 15, 2020

    Report

    Report Number
    MW5096673
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    July 1, 2020
    Report Date
    September 14, 2020
    Manufacturer
    THERMO FISHER SCIENTIFIC
    Product Code
    QKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MANDATORY WEARING OF A MASK OR FACE COVERING HAS SERIOUSLY THREATENED MY HEALTH. WEARING A MASK OVER MY MOUTH AND NOSE HAS CAUSED SEVERE HEADACHES, DIZZINESS AND BRAIN FOG. MY OXYGEN INTAKE IS INHIBITED AND I FEEL FAINT. LONG TERM EFFECTS HAVE BEEN EXTREME FATIGUE AND HEADACHE. OCCASIONALLY I ALSO EXPERIENCE SOME NAUSEA AND A SORE THROAT. MEDICAL DEVICES SUCH AS FACE MASKS SHOULD NEVER BE MANDATED BY POLITICIANS, NOR SHOULD THEY BE REQUIRED FOR GENERALLY HEALTHY INDIVIDUALS. ONLY A LICENSED MEDICAL DOCTOR AWARE OF AN INDIVIDUAL'S MEDICAL HEALTH CONDITIONS SHOULD BE AUTHORIZED TO RECOMMEND WEARING A MASK IN SPECIFIC SITUATIONS AND FOR A SPECIFIC LENGTH OF TIME. BACTERIAL COLLECTION INSIDE A MASK WORN INCORRECTLY OR FOR A PROLONGED TIME IS SERIOUSLY DETRIMENTAL TO MY HEALTH. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999828 FACE MASK FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER II QKR THERMO FISHER SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability