BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 556313 · Received August 24, 2004

    Report

    Report Number
    MW1033060
    Event Type
    Malfunction
    Date Received
    August 24, 2004
    Report Date
    August 19, 2004
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC MINIMED SOF-SET. SHEATH COVERING THE NEEDLE IS OFF, IN THE SEALED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED SOF-SET FPA MEDTRONIC MINIMED * 412000

    Patients

    Seq Age Sex Outcome Treatment
    1 *