BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM GREENFIELD VENA CAVA FILTER

    MDR report key: 20371 · Received March 17, 1995

    Report

    Report Number
    MW1005491
    Event Type
    Malfunction
    Date Received
    March 17, 1995
    Date of Event
    February 12, 1995
    Report Date
    March 3, 1995
    Manufacturer
    MEDI-TECH, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF VENA CAVA FILTERING DELIVERY SYSTEM. FILTER RELEASED IN THE SHEATH PRIOR TO WHEN IT WAS SUPPOSED TO BE RELEASED. RELEASE TRIGGER REMAINED IN "LOCKED" POSITION WITH SEAL INTACT. HAD TO BE RESTARTED IN THE CAROTID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM GREENFIELD VENA CAVA FILTER DTK MEDI-TECH, INC. 50-300 203807

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other