BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOFINE (32G) (NEEDLE) NA

    MDR report key: 2062757 · Received April 7, 2011

    Report

    Report Number
    9681821-2011-00017
    Event Type
    Other
    Date Received
    April 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K062500
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BROKE OFF AND GOT STUCK IN THE INJECTION SITE [NEEDLE ISSUE]. CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. (B)(4). THIS CASE (NOT AVAILABLE TO SENDER) FROM (B)(6) WAS REPORTED BY A CONSUMER AS "NEEDLE BROKEN OFF AND GOT STUCK IN THE INJECTION SITE", AND CONCERNS A MALE PT, AGE UNK USING NOVOFINE 32G 6 MM (NEEDLE) FROM AN UNK DATE TO AN UNK DATE DUE TO DIABETES MELLITUS. PT'S HEIGHT: NOT REPORTED. MEDICAL HISTORY: DIABETES MELLITUS FOR MORE THAN 10 YEARS. ON AN UNK DATE THE PT EXPERIENCED THAT THE NEEDLE BROKEN OFF AND GOT STUCK IN THE INJECTION SITE. IT WAS LEFT THERE FOR SEVERAL DAYS AS THE PHYSICIAN DID NOT RECOGNIZE ANYTHING ON THE X-RAY PHOTOGRAPH. THE PT WENT TO SEE HIS SURGEON, WHO OPENED THE TISSUE ON THE INJECTION SITE, POINTED OUT BY THE PT, FOUND THE PIECE OF NEEDLE AND REMOVED IT. THE OUTCOME WAS REPORTED AS "RECOVERED".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention