BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL MASK

    MDR report key: 11595122 · Received March 30, 2021

    Report

    Report Number
    MW5100399
    Event Type
    Injury
    Date Received
    March 30, 2021
    Date of Event
    March 28, 2021
    Report Date
    March 28, 2021
    Manufacturer
    UNK
    Product Code
    FXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PUTTING TODAY'S DATE AS THIS HAS HAPPENED SINCE THE ONSET OF WHEN MASK MANDATES WENT INTO EFFECT. MY TOURETTE'S SYNDROME IS INTENSIFIED WHEN WEARING A MASK AT WORK OR IN A PRIVATE BUSINESS SETTING THAT REQUIRES MASKS TO BE WORN. MY INTENSE MOTOR TICS/ JERKING OF THE BODY CAUSED BY MY TS, HAS LEFT ME WITH MANY PULLED MUSCLES AND HEADACHES. MASKING CREATES ANXIETY AND MENTAL ANGUISH OVER THE FEELING OF IMPRISONMENT WHEN NOT BEING ABLE TO SEE OTHERS FACES AS WELL. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490120 SURGICAL MASK MASK, SURGICAL FXX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other