BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FACE MASK

    MDR report key: 13456503 · Received February 3, 2022

    Report

    Report Number
    MW5107218
    Event Type
    Injury
    Date Received
    February 3, 2022
    Date of Event
    February 2, 2022
    Report Date
    February 3, 2022
    Manufacturer
    MOLDEX/METRIC, INC.
    Product Code
    QKR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    003
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CALLER STATED THAT SHE WORE A FACE MASK ON (B)(6) 2022 TO A DOCTORS APPOINTMENT AND SUFFERED ITCHING, REDNESS, RASH, OVER HER EYES, FACE, NECK AND ARMS. LATER SHE STARTED FEELING A HEADACHE. SHE TOOK BENADRYL TO HELP WITH THE ITCHING. SHE CALLED THE NUMBER ON THE BOX AND WAS TOLD THEY WILL SEND HER ANOTHER N95 MASK WHICH IS HYPOALLERGENIC BUT SHE DECLINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683436 FACE MASK FACE MASK PER ENFORCEMENT POLICY FOR FACE QKR MOLDEX/METRIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention