BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE FILTER

    MDR report key: 1415028 · Received July 13, 2009

    Report

    Report Number
    MW5011947
    Event Type
    Injury
    Date Received
    July 13, 2009
    Date of Event
    October 18, 2007
    Report Date
    July 13, 2009
    Manufacturer
    CORDIS
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A MALE H/O HYPERTENSION, H/O DVT, S/P PROSTATECTOMY. ADMITTED FOR DIZZINESS AND UNSTEADY GAIT- FOUND TO HAVE MENINGIO- S/P CRANIOTOMY. B/1 LOWER EXTREMITY SWELLING. DUPLEX US REVEALED LEFT POSTERIOR TIBIAL DVT, PATENT ILIACS & VENA CAVA WITH RECENT H/O CRANIOTOMY. IVC FILTER PLACED AND PATIENT WAS DISCHARGED HOME. PATIENT PRESENTED TO THE CLINIC -POD 42- WITH B/1 LOWER EXTREMITY SWELLING / DIFFICULTY WITH AMBULATION. LOWER EXTREMITY DUPLEX US DEMONSTRATED A NEW B/1 ILIO-CAVAL THROMBOSIS. DATES OF USE: 2000 - 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEASE FILTER TRAPEASE FILTER DTK CORDIS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O