BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOFINE 8MM (30G)

    MDR report key: 3131290 · Received May 20, 2013

    Report

    Report Number
    9681821-2013-00018
    Event Type
    Other
    Date Received
    May 20, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 22, 2013
    Manufacturer
    NOVO NORDISK A/S
    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

    NOVOFINE 30G BROKE OFF [NEEDLE ISSUE]. CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH AREA? NO. THIS SERIOUS SPONTANEOUS CASE REPORTED BY A CONSUMER FROM (B)(6), CONCERNS A (B)(6) MALE PATIENT WHO WAS TREATED WITH NOVOFINE 8 MM (30 G) (NEEDLE) ON UNKNOWN DATES FOR DEVICE THERAPY AND EXPERIENCED "NOVOFINE 30 G BROKE OFF" BEGINNING ON (B)(6) 2013. ON (B)(6) 2013, A NOVOFINE 30 G (BATCH NO: 12D08L) BROKE OFF IN THE PATIENT'S ABDOMEN DURING USE. THE NEEDLE HAD BEEN USED FOR 3 TIMES WHEN THE EVENT OCCURRED. ON (B)(6) 2013, THE PATIENT UNDERWENT AN OPERATION, BUT THE BROKEN NEEDLE WAS NOT REMOVED. ACTION TAKEN TO NOVOFINE 8 MM (30 G) (NEEDLE) WAS NOT REPORTED. THE OVERALL OUTCOME OF EVENT WAS REPORTED AS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223341 NOVOFINE 8MM (30G) NEEDLE FMI NOVO NORDISK A/S NA 12D08L

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention