BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRAPEASE

    MDR report key: 553480 · Received September 2, 2004

    Report

    Report Number
    MW1033147
    Event Type
    Death
    Date Received
    September 2, 2004
    Report Date
    September 2, 2004
    Manufacturer
    J & J CORDIS
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT HAD FILTER PLACED UNDER ABDOMEN AFTER OPEN HEART SURGERY. THE DAY AFTER THEY WERE DISCHARGED FROM THE HOSPITAL, THEY DIED ON THE WAY TO THE HOSPITAL. AFTER AN AUTOPSY OF CHEST-RE-OPENING THE CHEST AT THE SAME PLACE HAD HEART SURGERY-THE TRAPEASE FILTER HAD MIGRATED TO HEART, WHICH, ACCORDING TO THE DEATH CERTIFICATE, WAS THE CAUSE OF DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death