BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMIRA PEN (2/BOX)

    MDR report key: 10338386 · Received July 28, 2020

    Report

    Report Number
    MW5095780
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 24, 2020
    Manufacturer
    ABBVIE, INC.
    Product Code
    NSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL FROM MEMBER CALLED INTO SPEAK WITH RPH ABOUT INCIDENT WITH HUMIRA PEN. MEMBER STATED THE NEEDLE CAME OUT BEFORE INJECTING. PATIENT'S DOSE WAS DUE SUNDAY. PATIENT ADVISED TO CONTACT ABBVIE FOR REPLACEMENT. UNKNOWN IF PATIENT STILL HAS DEFECTIVE PRODUCT ON HAND, HAD ANY ADVERSE REACTIONS OR MISSED DOSE. NO FURTHER INFORMATION. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800572 HUMIRA PEN (2/BOX) INJECTOR, PEN NSC ABBVIE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR