BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSURE

    MDR report key: 1250824 · Received November 29, 2008

    Report

    Report Number
    3006380458-2008-00006
    Event Type
    Malfunction
    Date Received
    November 29, 2008
    Date of Event
    September 29, 2008
    Report Date
    November 29, 2008
    Manufacturer
    FEEL TECH
    Product Code
    FMF
    PMA / PMN Number
    K070917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT STATES THAT THE INSULIN SYRINGE NEEDLE PULLS OUT AND REMAINS IN THE PT AFTER GIVING INJECTION OF SUBCUTANEOUS DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSURE INSULIN SYRINGE FMF FEEL TECH

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK