BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE-30GX8MM AUTOCOVER

    MDR report key: 7973583 · Received October 16, 2018

    Report

    Report Number
    MW5080614
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 8, 2018
    Manufacturer
    NOVO NORDISK INC.
    Product Code
    FMI
    UDI-DI
    00169185275
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    SPOKE WITH PT'S MOM. PT UNABLE TO USE THE AUTOCOVER NEEDLES. HE MISSED 2 DOSES AS A RESULT (JUST TOLD HIS MOM TODAY). I RE-ENTERED NEEDLES TO BE SAME SIZE, BUT WITHOUT THE AUTOCOVER. PCC WILL SUS FOR TOMORROW. FREQUENCY: DAILY, SUBCUTANEOUS; 2016 - PRESENT. DIAGNOSIS OR REASON FOR USE: E23.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813032 NOVOFINE-30GX8MM AUTOCOVER NEEDLE, HYPODERMIC, SINGLE LUMEN FMI NOVO NORDISK INC. 00169185275

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR