BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE AND WHITE MEDICAL MASK

    MDR report key: 11634073 · Received April 7, 2021

    Report

    Report Number
    MW5100655
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 20, 2021
    Report Date
    April 6, 2021
    Manufacturer
    UNK
    Product Code
    QKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ALLERGIC REACTION; I HAD AN ALLERGIC REACTION TO THE BLUE AND WHITE MASKS. MY MASK WASN'T UP TO THE BUSINESS STANDARD AND GIVEN THIS MASK WITH NO OTHER OPTION MENTIONED TO ME. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523011 BLUE AND WHITE MEDICAL MASK FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE COVID QKR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other