BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE PLS MIS 32GX4MM

    MDR report key: 9967602 · Received April 15, 2020

    Report

    Report Number
    MW5094164
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    April 14, 2020
    Report Date
    April 14, 2020
    Manufacturer
    NOVO NORDISK INC.
    Product Code
    FMI
    UDI-DI
    00169185550
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A BOX OF PEN NEEDLES WITH THE DIRECTIONS TO USE WITH NORDITROPIN INSTEAD OF STATING TO USE WITH NUTROPIN AS IT SHOULD HAVE. NO EVIDENCE TO SHOW THAT THIS CAUSED ANY INTERRUPTION IN THERAPY OR PROBLEMS. DATES OF USE: (B)(6) 2019 TO PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429668 NOVOFINE PLS MIS 32GX4MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI NOVO NORDISK INC. 00169185550

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR