BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE-32 DISP NEEDLES

    MDR report key: 8518737 · Received April 15, 2019

    Report

    Report Number
    MW5085886
    Event Type
    Injury
    Date Received
    April 15, 2019
    Date of Event
    February 26, 2019
    Report Date
    February 26, 2019
    Manufacturer
    NOVO NORDISK INC.
    Product Code
    FMI
    UDI-DI
    00169185189
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S MOTHER REPORTED PEN NDL 32G 15/64 IN (6MM) CAUSING INJECTION PAIN. DISCUSSED OPTIONS AND MOM WILL CONTACT DR FOR 4MM PEN NEEDLE RX SINCE WILL NEED RX DUE TO POSSIBLE COMPATIBILITY ISSUES AND SEND TO PHARMACY. CONTINUING MED UNTIL NEW NEEDLE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306723 NOVOFINE-32 DISP NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI NOVO NORDISK INC. 00169185189

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR