BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 32G 6MM

    MDR report key: 3955157 · Received July 18, 2014

    Report

    Report Number
    9681821-2014-00034
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    July 7, 2014
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMF
    PMA / PMN Number
    K090111
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE BROKE OFF DURING INJECTION [NEEDLE ISSUE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY CONSUMER AS "NEEDLE BROKE OFF DURING INJECTION" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A FEMALE PT WHO WAS BORN ON UNK DATE IN 1947 AND WAS USING WITH NOVOFINE 32G 6MM (NEEDLE) FROM AN UNK START DATE DUE TO "DEVICE THERAPY". PT'S HEIGHT, WEIGHT, BODY MASS INDEX WERE NOT REPORTED. MEDICAL HISTORY WAS NOT PROVIDED. IT WAS REPORTED THAT, THE NEEDLE BROKE OFF DURING INJECTION AND THE PT WENT TO THE HOSPITAL TO GET IT REMOVED. ON AN UNK DATE, THE BROKEN OFF NEEDLE WAS REMOVED IN THE HOSPITAL THROUGH SURGERY. ACTION TAKEN TO NOVOFINE 32G 6MM WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "NEEDLE BROKE OFF DURING INJECTION" WAS NOT REPORTED. NO SAMPLE WILL BE SENT AS PT HAS DISCARDED THE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423230 NOVOFINE 32G 6MM NEEDLE FMF NOVO NORDISK A/S NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention