BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK

    MDR report key: 1961014 · Received January 10, 2011

    Report

    Report Number
    MW5018965
    Event Type
    Death
    Date Received
    January 10, 2011
    Date of Event
    January 24, 2010
    Report Date
    January 10, 2011
    Manufacturer
    COOK
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RE: COOK CELECT VEN CAVA FILTER (B)(4) LOT 2489282. THE INCIDENT HAPPENED AT (B)(6) HOSPITAL IN (B)(6) ON (B)(6) 2020. THE FILTER WAS BEING PUT IN THE VENA CAVA AND FAILED TO OPEN. THE FILTER TRAVELED UP THRU THE HEART AND WENT TO THE DISTAL PART OF THE LUNG. PATIENT DIED OF A PULMONARY EMBOLISM. ON AUTOPSY, THERE WERE BLOOD CLOTS FORMED AROUND THE FILTER IN THE LUNG. I RECEIVED THE MAUDE REPORT ON THE FILTER THRU THE RIGHT TO KNOW ACT. THIS INCIDENT WAS NOT IN THE REPORT. I AM COMPLAINING THAT THIS WAS NOT REPORTED AS A MEDICAL DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK COOK CELECT VENA CAVA FILTER DTK COOK 2489282

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death