BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE VENACAVA FILTER FEMORAL

    MDR report key: 1842647 · Received September 20, 2010

    Report

    Report Number
    MW5017505
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 8, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH RECENT HISTORY OF DVT ON (B)(6)2010. IVC FILTER PLACED (B)(6)2010 PRIOR TO CHOLECYSTECTOMY. THE PT WAS READMITTED (B)(6)2010 WITH COMPLAINTS OF LEFT LOWER QUADRANT PAIN AND PAIN "SHAPED LIKE A DIAMOND" IN UPPER LUMBAR AREA WHICH INCREASES WITH VALSALVA AND MOVEMENT. INFERIOR VENA CAVAGRAM ON (B)(6)2010 DEMONSTRATES LEG PROTRUSION THROUGH THE LEFT SIDE OF THE INFERIOR VENA CAVA. PT REQUIRED TRANSFER TO ANOTHER FACILITY FOR SURGICAL REMOVAL OF IVC FILTER AND REPLACEMENT FILTER. DATES OF USE: (B)(6) - (B)(6)2010. DIAGNOSIS OR REASON FOR USE: DVT LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE VENACAVA FILTER FEMORAL G2 IVC FILTER DTK BARD PERIPHERAL VASCULAR GFUB 1654

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention