BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUMEROUS

    MDR report key: 11647989 · Received April 9, 2021

    Report

    Report Number
    MW5100678
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    May 3, 2020
    Report Date
    April 7, 2021
    Manufacturer
    UNK
    Product Code
    QKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WEARING A MASK CAUSED ME TO HAVE SINUS ISSUES, NOSE BLEEDS AND OTHER REACTIONS THAT NEVER OCCURRED BEFORE. I HAVE SINCE OBTAINED A MEDICAL EXEMPTION, BUT HAVE ONGOING ISSUES WHENEVER THE EXEMPTION IS NOT ACCEPTED. MY COLLEGE STUDENT DAUGHTER HAS HAD PERSISTENT FACIAL ACNE AND MIGRAINES AGAIN FROM MANDATED MASKING. ALL MASKS THAT COVER MOUTH AND N. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541532 NUMEROUS FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR