BEUDAMED
    FDA Adverse Event Death Summary report: N

    COVIDIEN-US SURGICAL

    MDR report key: 2614697 · Received June 7, 2012

    Report

    Report Number
    MW5025721
    Event Type
    Death
    Date Received
    June 7, 2012
    Date of Event
    May 18, 2012
    Report Date
    June 7, 2012
    Manufacturer
    COVIDIEN US SURGICAL
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUTURE CRACKED. A 6-0 COVIDIEN SUTURE GRAFTS ON THE AORTA UNRAVEL. PT HAD PERICARDIAL TAMPONADE, UNABLE TO RESUSCITATE AND PT EXPIRED IN OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN-US SURGICAL ENDOGIA RELOAD WITH TRISTAPLE 60MM MED THICK GDW COVIDIEN US SURGICAL 6-0 SUTURE

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death