BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE/WHITE SURGICAL AND CLOTH MASK

    MDR report key: 11641009 · Received April 8, 2021

    Report

    Report Number
    MW5100675
    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 GETS SEVERE NOSE BLEEDS, HEADACHES, DIZZINESS, AND FATIGUE. SHE ALSO HAS TROUBLE CONCENTRATING ON HER HOMEWORK. SHE IS MASKED WHEN SHE IS AT SCHOOL AND WHILE AT BASKETBALL AND VOLLEYBALL PRACTICES AND AT GAMES. I TOOK HER TO THE DOCTOR AND SHE RECEIVED A MEDICAL MASK EXEMPTION. HER SCHOOL SUPERINTENDENT WILL NOT HONOR IT. HE IS REQUESTING MORE INFORMATION, IN THE FORM OF MEDICAL RECORDS FROM (B)(6) 2020-NOW. I WILL NOT PROVIDE THAT INFORMATION, IT IS PRIVATE. FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529717 BLUE/WHITE SURGICAL AND CLOTH MASK FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK
    529718 BLUE/WHITE SURGICAL AND CLOTH MASK FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention| S