BEUDAMED
    FDA Adverse Event Death Summary report: N

    TYCO HEALTHCARE

    MDR report key: 1013213 · Received March 12, 2008

    Report

    Report Number
    1013213
    Event Type
    Death
    Date Received
    March 12, 2008
    Date of Event
    November 30, 2007
    Report Date
    March 7, 2008
    Manufacturer
    AUTO SUTURE (U.S. SURGICAL)
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2007, ENDOSCOPIC HERNIA REPAIR WAS DONE BY ABDOMINAL HERNIA. PATIENT CODED 2 DAYS LATER AT 4:19 AM AND EXPIRED. UPON AUTOPSY IT WAS DISCOVERED THAT A SURGICAL FASTENER (STAPLE) FROM THE PROTACK DEVICE HAD COME LOOSE AND MIGRATED TO PATIENTS' PERICARDIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO HEALTHCARE ENDOSCOPIC MESH FASTENER GDW AUTO SUTURE (U.S. SURGICAL) PTACK 30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death ETHICON PORTS| GORE MESH