BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENACAVA FEMORAL RECOVERY FILTER

    MDR report key: 1040897 · Received May 12, 2008

    Report

    Report Number
    MW5006815
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 2, 2008
    Manufacturer
    BARD
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BARD RECOVERY FILTER PLACED IN PATIENT IN 2005. IN 2008, AFTER ECHO - CARDIOGRAM AND CATHETERIZATION, FRACTURED LIMBS WERE SEEN WITHIN RIGHT VENTRICLE. CT SCAN PERFORMED WHICH SHOWED 3 SEPARATE FRACTURED LIMBS OF THE DEVICE AND THEIR LOCATION WITHIN THE RIGHT VENTRICLE AS WELL AS THE SEPTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENACAVA FEMORAL RECOVERY FILTER DTK BARD RF-048F 07142038

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention