BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE

    MDR report key: 3926079 · Received June 30, 2014

    Report

    Report Number
    9681821-2014-00032
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 5, 2014
    Manufacturer
    NOVO NORDISK A/S -
    Product Code
    FMF
    PMA / PMN Number
    K861686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEVERAL NOVOFINE NEEDLES DISAPPEARED POSSIBLY INTO THE PATIENT'S BODY (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 HEALTH CARE PROFESSIONAL (CERTIFIED DIABETES EDUCATOR) AS "SEVERAL NOVOFINE NEEDLES DISAPPEARED POSSIBLY INTO THE PATIENT'S BODY" BEGINNING ON AN UNSPECIFIED DATE IN 2014, AND CONCERNED A (B)(6)-YEAR-OLD MALE PATIENT WHO WAS USING NOVOFINE NEEDLES (GAUGE UNSPECIFIED) FROM UNKNOWN START DATE DUE TO TYPE 2 DIABETES MELLITUS (PRODUCT USE: ONGOING). PATIENT'S HEIGHT: NOT REPORTED. PATIENT'S WEIGHT: NOT REPORTED. PATIENT'S BMI (BODY MASS INDEX): NOT REPORTED. MEDICAL HISTORY INCLUDES TYPE 2 DIABETES MELLITUS (DURATION NOT REPORTED). THE PATIENT WAS TAKING NOVOLOG FLEXPEN WITH THE NOVOFINE NEEDLES. A CERTIFIED DIABETES EDUCATOR (CDE) REPORTED THAT IN THE LAST THREE WEEKS "SEVERAL NOVOFINE NEEDLES DISAPPEARED POSSIBLY INTO THE PATIENT'S BODY". THE CDE STATED THAT SHE WAS NOT SURE IF IT WAS CONFIRMED THAT THE NEEDLES WERE STUCK IN THE PATIENT'S BODY OR IF THE PATIENT HAD ANY TREATMENT TO GET THE NEEDLES REMOVED. ACTION TAKEN TO NOVOFINE WAS REPORTED AS NO CHANGE. THE OUTCOME FOR THE EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378660 NOVOFINE NEEDLE FMF NOVO NORDISK A/S - NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other SOLUTION FOR INJECTION, 100U/ML| NOVOLOG FLEX PEN (INSULIN ASPART)