BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENFIELD

    MDR report key: 68716 · Received January 10, 1997

    Report

    Report Number
    68716
    Event Type
    Malfunction
    Date Received
    January 10, 1997
    Date of Event
    October 10, 1996
    Report Date
    October 17, 1996
    Manufacturer
    MEDITECH, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VENA CAVA FILTER TIP CAME OFF WHEN PHYSICIAN WAS PREPARING TO INSERT IN RIGHT FEMORAL. SAME OCCURRED WHEN SECOND FILTER WAS PREPARED FOR INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENFIELD Implant VENA CAVA FILTER DTK MEDITECH, INC. 50-401 332586,341789

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other