BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOFINE (30G)

    MDR report key: 2987924 · Received February 21, 2013

    Report

    Report Number
    9681821-2013-00007
    Event Type
    Other
    Date Received
    February 21, 2013
    Report Date
    January 25, 2013
    Manufacturer
    NOVO NORDISK A/S MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K861686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE BROKE IN ABDOMEN (NEEDLE ISSUE). CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH THREAT? NO. THIS SERIOUS SPONTANEOUS CASE REPORTED BY A CONSUMER (PT'S MOTHER) FROM DENMARK, CONCERNS A (B)(6) MALE PT WITH "DIABETES MELLITUS" WHO WAS TREATED WITH NOVOFINE 30G (NEEDLE) ON AN UNK DATE AND EXPERIENCED BROKEN "NEEDLE IN THE ABDOMEN" BEGINNING ON AN UNK DATE. PT'S HEIGHT NOT REPORTED. MEDICAL HISTORY INCLUDES DIABETES MELLITUS (FOR 6 YEARS). ON AN UNK DATE. THE PT'S MOTHER INFORMED THAT THEY HAD TO GO TO THE DOCTOR IN THE EVENING FOR HAVING A NEEDLE REMOVED AS IT WAS BROKEN AFTER THE PT TOOK HIS INSULIN AND SOME OF THE NEEDLE WAS IN HIS ABDOMEN. THE PT ALWAYS USED 8 M NEEDLES AND HAD NEVER EXPERIENCED THIS BEFORE. THE OVERALL OUTCOME OF EVENT WAS REPORTED AS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75352 NOVOFINE (30G) NEEDLE FMF NOVO NORDISK A/S MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention