BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAPEN3

    MDR report key: 250461 · Received November 17, 1999

    Report

    Report Number
    MW1017563
    Event Type
    Malfunction
    Date Received
    November 17, 1999
    Date of Event
    November 1, 1999
    Report Date
    November 17, 1999
    Manufacturer
    NOVO NORDISK PHARMACEUTICALS INC.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PENS ARE LEAKING. THIS IS SECOND PEN. THE FIRST WAS REPORTED 9/17/99, USED BY A DIFFERENT PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAPEN3 INSULIN INJECTOR KZE NOVO NORDISK PHARMACEUTICALS INC. NA HW40009

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other NOVOLIN 70/30