BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON

    MDR report key: 208762 · Received February 4, 1999

    Report

    Report Number
    208762
    Event Type
    Death
    Date Received
    February 4, 1999
    Date of Event
    January 28, 1999
    Report Date
    January 28, 1999
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT S/P CORONARY ARTERY BYPASS GRAFT X 4 1/27/1999. ON 1/28/1998, PT. WAS SITTING UP AND SUDDENLY HAD LARGE AMOUNT OF BLOOD DUMP INTO CHEST TUBES, THEN WENT INTO FULL CARDIAC ARREST. THE CHEST WAS OPENED IMMEDIATELY, OPEN COMPRESSIONS OF HEART BEGUN, AND SURGEON NOTED PROXIMAL GRAFT PULLED AWAY FROM AORTA. PT TAKEN TO OR WHERE CARDIAC SURGEON NOTED A SUTURE WAS BROKEN. ATTEMPTS TO RESUSCITATE PT UNSUCCESSFUL AND PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON Implant 6-0 PROLENE SUTURE GAW ETHICON, INC. * LKE848

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death