BEUDAMED
    FDA Adverse Event Death Summary report: N

    COVIDIEN SURGICAL SOLUTIONS

    MDR report key: 2794215 · Received October 10, 2012

    Report

    Report Number
    2794215
    Event Type
    Death
    Date Received
    October 10, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 8, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PT UNDERWENT CABG AND MVR. APPROX 6-7 HRS AFTER SURGERY COMPLETED, PT DEVELOPED BLEED VIA CHEST TUBE, HYPOTENSION. CT SURGERY OPENED CHEST, REPORT IT APPEARED IVC SUTURE HAD FRACTURED. RESUSCITATION UNSUCCESSFUL. PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN SURGICAL SOLUTIONS SURGI PRO SUTURE GAW COVIDIEN 3-0 SURGI PRO V20 01M0533X

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death