BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENBREL MINI

    MDR report key: 11506807 · Received March 16, 2021

    Report

    Report Number
    MW5100052
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    March 9, 2021
    Report Date
    March 10, 2021
    Manufacturer
    AMGEN INC. / IMMUNEX CORPORATION
    Product Code
    NSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT REPORTS DEFECTIVE DEVICE THAT THE NEEDLE GOT STUCK AND DOSE WAS NOT ADMINISTERED. PATIENT RECEIVED A SAMPLE FROM THE MD, SO SHE DIDN'T MISS HER DOSE. "UNKNOWN IF." REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396466 ENBREL MINI INJECTOR, PEN NSC AMGEN INC. / IMMUNEX CORPORATION 1120570

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR