BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 15673443 · Received October 26, 2022

    Report

    Report Number
    2411236-2022-00004
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    September 28, 2022
    Report Date
    October 5, 2022
    Manufacturer
    AMD MEDICOM
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    A 68 YEAR OLD FEMALE UNIT CLERK, HAD REDNESS, SEVERE SWELLING AND BLISTERING ON FACE, WORSE WHERE THE MASK WAS. THEIR VOICE WAS HOARSE AND FELT LIKE THEIR THROAT WAS CLOSING UP. THIS HAPPENED SEVERAL TIMES FROM WEARING THE MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2599418 HENRY SCHEIN EARLOOP MASK FXX AMD MEDICOM T2201

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization