BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE/WHITE SURGICAL

    MDR report key: 11640742 · Received April 8, 2021

    Report

    Report Number
    MW5100663
    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 SON GETS SEVERE HEADACHES, FATIGUE, DIZZINESS. HE SLEEPS A LOT, HE CANNOT BREATHE AND COUGHS WHEN MASKED. HE HAS HAD TO HAVE ABSCESSED TEETH PULLED. HE LOOKS GREEN IN THE FACE WHEN HE COMES HOME FROM SCHOOL. HE IS REQUIRED TO MASK FOR 9+ HOURS A DAY IN SCHOOL. NO MASK BREAKS EXCEPT FOR LUNCH, EVEN DURING OUTSIDE RECESS, HE IS MASKED. WE TOOK HIM TO THE DOCTOR AND RECEIVED A MEDICAL MASK EXEMPTION. THE SCHOOL SUPERINTENDENT WILL NOT HONOR IT. HE IS REQUESTING MY SON'S MEDICAL RECORDS FROM (B)(6) 2020-NOW. I WILL NOT PROVIDE THAT INFORMATION TO THEM. IT IS PRIVATE. (B)(6). FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529694 BLUE/WHITE SURGICAL FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK
    529695 CLOTH MASKS FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention| S