BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA CAVA FILTER

    MDR report key: 21672 · Received April 6, 1995

    Report

    Report Number
    21672
    Event Type
    Injury
    Date Received
    April 6, 1995
    Date of Event
    March 13, 1995
    Report Date
    March 16, 1995
    Manufacturer
    MEDITECH, INC.
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENA CAVA FILTER INSERTED UNDER FLUOROSCOPY. APPARENTLY FILTER DID NOT FULLY OPEN IN THE INFERIOR VENA CAVA. IT FLOATED TO THE RIGHT ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENA CAVA FILTER Implant FEMORAL FILTER DTK MEDITECH, INC. 213061

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening