BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE/WHITE SURGICAL AND CLOTH MASKS

    MDR report key: 11640729 · Received April 8, 2021

    Report

    Report Number
    MW5100662
    Event Type
    Injury
    Date Received
    April 8, 2021
    Report Date
    April 7, 2021
    Manufacturer
    UNK
    Product Code
    QKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY DAUGHTER HAS SEVERE NOSE BLEEDS, RED RASH ON HER CHIN AND CHEEKS. SHE ALSO GETS HEADACHES AND HAS TROUBLE CONCENTRATING IN SCHOOL. SHE IS MASKED FOR 9+ HOURS DAILY. WE TOOK HER TO THE DOCTOR AND RECEIVED A MEDICAL MASK EXEMPTION BUT THE SCHOOL SUPERINTENDENT WILL NOT HONOR IT. HE IS REQUESTING HER MEDICAL RECORDS FROM (B)(6) 2020-NOW. I WILL NOT PROVIDE THAT INFORMATION TO ANYONE, IT IS PRIVATE. (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529702 BLUE/WHITE SURGICAL AND CLOTH MASKS FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Disability