BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE FACE MASK

    MDR report key: 10605836 · Received September 29, 2020

    Report

    Report Number
    MW5096947
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    September 25, 2020
    Report Date
    September 25, 2020
    Manufacturer
    HUBEI KIMSOUL INDUSTRIAL CO. LTD.
    Product Code
    QKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FACE TURNED RED AND ITCHED FOLLOWING VERY BRIEF WEARING OF FACE MASK. LIPS NUMB, FACE CONTINUED TO BE IRRITATED FOR SOMETIME AFTER USE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065738 DISPOSABLE FACE MASK FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER II QKR HUBEI KIMSOUL INDUSTRIAL CO. LTD. KS-1018

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR