BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL GRADE MASK

    MDR report key: 11677665 · Received April 15, 2021

    Report

    Report Number
    MW5100797
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    October 8, 2020
    Report Date
    April 13, 2021
    Manufacturer
    UNK
    Product Code
    QKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY NEW JOB REQUIRED A 12 HOUR SHIFT IN A MEDICAL MASK. NO BREAK, WITH THE EXCEPTION OF LUNCH. AT THE END OF THE 1ST DAY, I EXPERIENCED A MIGRAINE (WHICH I AM PRONE TO). I CHALKED UP THE EXPERIENCE TO STARTING A NEW JOB. AT THE END OF THE 2ND, 12 HOUR SHIFT, I AGAIN EXPERIENCED A MIGRAINE. DUE TO THIS, I WAS UNABLE TO COMPLETE THE TASKS REQUIRED OF MY NEW JOB AND HAD TO RESIGN. THE CONTINUING INSISTENCE ON MASKS AS AN NPI IS SHORT SIGHTED AND NOT BASED ON SCIENCE. YOU ARE WELL AWARE THAT A MEDICAL MASK IS NOT EFFECTIVE IN CONTROLLING SPREAD BY AEROSOLS. FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568245 MEDICAL GRADE MASK FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR