BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE (32G)

    MDR report key: 3800298 · Received May 2, 2014

    Report

    Report Number
    9681821-2014-00017
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 4, 2014
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMI
    PMA / PMN Number
    K062500
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE STUCK IN ABDOMEN [NEEDLE ISSUE]. CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH THREAT? NO. THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "NEEDLE STUCK IN ABDOMEN" BEGINNING ON (B)(6) 2014, AND CONCERNED A (B)(6)-YEAR-OLD FEMALE PT USING NOVOFINE 32G NEEDLE FROM AN UNK DATE "MANY YEARS AGO" AND ONGOING, DUE TO TYPE 1 DIABETES MELLITUS. PT'S HEIGHT: 160 CM. PT'S WEIGHT: 81 KG. MEDICAL HISTORY INCLUDES TYPE 1 DIABETES MELLITUS FROM 1977 AND HYPERTHYROIDISM. THE PT HAD A PAST HISTORY OF CELLULITIS. A PT REPORTED THAT SHE WAS USING NOVOFINE 32G NEEDLES WITH SYMLINPEN (PRAMLINTIDE) AND THE NOVOFINE NEEDLE GOT STUCK IN HER ABDOMEN ON (B)(6) 2014. AT THE TIME OF THE INITIAL REPORT, THE PT STATED THAT SHE HAD AN APPOINTMENT WITH HER PHYSICIAN WHO WOULD REMOVE THE NEEDLE FROM HER ABDOMEN LATER THAT DAY. THE OUTCOME FOR THE EVENT WAS REPORTED AS NOT RECOVERED. THE NEEDLES WILL NOT BE RETURNED AS THE PT WAS STILL USING THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264244 NOVOFINE (32G) NEEDLE FMI NOVO NORDISK A/S NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other SYMLINPEN (PRAMLINTIDE ACETATE)