BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2

    MDR report key: 1983533 · Received February 1, 2011

    Report

    Report Number
    1983533
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BARD
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH G2 INFERIOR VENA CAVA (IVC) FILTER PLACED APPROXIMATELY 17 MONTHS AGO CAME IN FOR REMOVAL. A LIMB WAS FOUND TO BE BROKEN OFF FROM THE DEVICE. THE FAMILY IS IN POSSESSION OF THE DEVICE AND NOT WILLING TO RELEASE IT TO THIS HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BARD RF400F GFTE3395

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR NO OTHER THERAPIES