BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOTWIST MIS 32GX5MM

    MDR report key: 7918761 · Received September 27, 2018

    Report

    Report Number
    MW5080191
    Event Type
    Injury
    Date Received
    September 27, 2018
    Date of Event
    September 18, 2018
    Report Date
    September 19, 2018
    Manufacturer
    NOVO NORDISK INC.
    Product Code
    FMI
    UDI-DI
    00169185389
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S MOM REPORTS HER SON GETTING A LARGE WELT THAT IS RED AND RAISED. THIS IS THE FIRST TIME HE HAS HAD THIS REACTION IN THE YEAR HE HAS BEEN ON THE MEDICATION. SHE REPORTS HE DOES SOMETIMES GET A BRUISE AFTER THE INJECTION. DATES OF USE: (B)(6) 2017 - PRESENT. THE PRODUCT IS COMPOUNDED; THE PRODUCT IS OVER-THE-COUNTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754106 NOVOTWIST MIS 32GX5MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI NOVO NORDISK INC. 00169185389

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO