BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINIE 30

    MDR report key: 163683 · Received April 15, 1998

    Report

    Report Number
    MW1013561
    Event Type
    Injury
    Date Received
    April 15, 1998
    Date of Event
    April 3, 1998
    Report Date
    April 15, 1998
    Manufacturer
    NOVO NORDISK PHARMACEUTICALS, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    NEEDLE BROKE OFF SUBCUTANEOUSLY IN ARM. PRIOR EVENT HAD NEEDLE BREAK OFF IN ABDOMINAL WALL SUBCUTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINIE 30 INSULIN DISPOSABLE NEEDLE FMI NOVO NORDISK PHARMACEUTICALS, INC. * 95M14B
    2 NOVOFINIE 30 INSULIN DISPOSABLE NEEDLE FMI NOVO NORDISK PHARMACEUTICALS, INC * 96E10B

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention