BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVO NORDISK AUTO COVER NEEDLES

    MDR report key: 1651101 · Received April 1, 2010

    Report

    Report Number
    MW5015413
    Event Type
    Malfunction
    Date Received
    April 1, 2010
    Manufacturer
    NOVO NORDISK
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SAFETY MECHANISM DID NOT TURN TO RED AFTER INJECTION WAS GIVEN. AFTER AUTO COVER WAS MANIPULATED AND AFTER SEVERAL ATTEMPTS BEFORE IT LOCKED. DATES OF USE: (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: INSULIN PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVO NORDISK AUTO COVER NEEDLES AUTO COVER NEEDLES KZE NOVO NORDISK 09H06U

    Patients

    Seq Age Sex Outcome Treatment
    1