BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOFINE (30G)

    MDR report key: 918288 · Received September 24, 2007

    Report

    Report Number
    9681821-2007-00044
    Event Type
    Other
    Date Received
    September 24, 2007
    Date of Event
    August 31, 2007
    Report Date
    August 31, 2007
    Manufacturer
    NOVO NORDISK A/S - MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K861686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE DISAPPEARED [MEDICAL DEVICE COMPLICATION]. CASE DESCRIPTION: THIS SPONTANEOUS CASE REPORTED BY CONSUMER, RECEIVED FROM ANOTHER COUNTRY REPORTED AS "NEEDLE DISAPPEARED", CONCERNS A FEMALE PT OF UNK AGE TREATED WITH NOVOFINE 30G FROM AN UNK ATE AND DURATION DUE TO DEVICE THERAPY. MEDICAL HISTORY NOT INCLUDED. IN 2007, THE PT FOUND THE NEEDLE HAD DISAPPEARED AFTER SHE ADMINISTERED THE INSULIN. THE PT SAID, IT WAS THE FIRST TIME SHE USED THIS NEEDLE . THE PT WENT TO SEE HER DOCTOR AND WAS TOLD THAT FURTHER EXAMINATION, X-RAY AND OBSERVATION WERE NEEDED. FURTHERMORE, THE NEEDLE WAS NOT EASY TO REMOVE. THE OVERALL OUTCOME WAS REPORTED "NOT YET RECOVERED". REPORTER'S CAUSALITY: UNK. NOVO NORDISK'S CAUSALITY: REPORTABLE. COMMENT: COMPANY COMMENT. FROM THE CURRENTLY AVAILABLE INFO IT IS NOT CLEAR WHETHER THE NEEDLE "WAS NOT EASY TO REMOVE" WHILE IT WAS PULLED OUT FROM THE BODY OF THE PT AFTER THE INJECTION OR IF THE STATEMENT REFERS TO THE REMOVAL OF THE NEEDLE BY A HEALTH CARE PROFESSIONAL. HOWEVER, NOVO NORDISK HAS ASSESSED THE CASE TO BE AN INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention