BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISETRONIC ULTRAFLEX

    MDR report key: 829287 · Received March 11, 2007

    Report

    Report Number
    MW1042239
    Event Type
    Injury
    Date Received
    March 11, 2007
    Report Date
    March 11, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEM AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MORE THAN 50% OF THE TIMES I HAVE USED THESE SUBCUTANEOUS INSULIN INFUSION SETS, THE SETS HAVE "KINKED" PREVENTING FLOW OF INSULIN INTO MY TISSUES. THIS OCCURS ALTHOUGH I RECHECK THE PRESCRIBED METHOD OF INSERTION. THIS PROBLEM HAS NOT BEEN EXPERIENCED WITH THIS FREQUENCY WITH OTHER SETS FROM OTHER MFRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISETRONIC ULTRAFLEX SUBCUTANEOUS INFUSION SET FOZ DISETRONIC MEDICAL SYSTEM AG * 4F005UF

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability DELTEC COZMO INSULIN PUMP