BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FACE MASK

    MDR report key: 11628753 · Received April 6, 2021

    Report

    Report Number
    MW5100597
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    January 25, 2021
    Report Date
    April 3, 2021
    Manufacturer
    UNK
    Product Code
    QKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MASK REQUIRED FOR TO, FROM AND DURING SCHOOL FOR A TOTAL OF 9 HOURS PER DAY. SPEECH PROGRESS DECLINED. SKIN BACTERIAL INFECTION ON JAWBONE, AND DIFFICULT BREATHING WITH ALLERGIES - CONSTANT COUGH. COMPANY: (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522974 FACE MASK FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Disability