BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMIRA PEN 40MG

    MDR report key: 10786374 · Received November 3, 2020

    Report

    Report Number
    MW5097648
    Event Type
    Injury
    Date Received
    November 3, 2020
    Report Date
    November 3, 2020
    Manufacturer
    ABBVIE INC.
    Product Code
    NSC
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT HE WAS GIVING HIMSELF HIS INSULIN INJECTION USING HUMIRA PEN, THE PEN DID NOT ENGAGE INSTEAD LEAKED THE MEDICATION ALL OVER THE FLOOR. NO MEDICATION WAS RECEIVED, FAULTY PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247684 HUMIRA PEN 40MG INJECTOR, PEN NSC ABBVIE INC. 1133416

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention