BEUDAMED
    FDA Adverse Event Death Summary report: N

    COVIDIEN

    MDR report key: 2371335 · Received December 6, 2011

    Report

    Report Number
    2371335
    Event Type
    Death
    Date Received
    December 6, 2011
    Date of Event
    November 17, 2011
    Report Date
    December 5, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE ADMITTED IN TRANSFER FROM LOCAL FACILITY ED WITH A 2 DAY HISTORY OF VOMITING WITH HEMATEMESIS. DIAGNOSED BY CT SCAN SHOWED LARGE MORGAGNI HERNIA WITH COLON AND PORTION OF STOMACH IN HERNIA DEFECT CAUSING GASTRIC OUTLET OBSTRUCTION. PT TAKEN TO THE OPERATING ROOM ON (B)(6) FOR LAPAROSCOPIC DIAPHRAGMATIC HERNIA REPAIR WHERE GRAFT MESH SECURED USING PROTACK DEVICE. PT TOLERATED PROCEDURE WELL. THE PT BECAME HYPOTENSIVE AND BRADYCARDIC DURING RECOVERY IN PACU, AND FOUND TO HAVE A PERICARDIAL EFFUSION ON ECHO. HE WAS TAKEN EMERGENTLY BACK TO THE OPERATING ROOM FOR A STERNOTOMY AND REPAIR OF A RIGHT VENTRICLE CARDIAC LACERATION. PT REMAINED VERY UNSTABLE IN THE OPERATING ROOM AND HAD A TRANSVENOUS PACEMAKER PLACED AND WAS TRANSFERRED TO A FACILITY WITH CARDIAC SURGERY CAPABILITY FOR FURTHER CARE. PT WAS STABILIZED THERE FOR A SHORT PERIOD OF TIME WHEN HE HAD A FULL CARDIAC ARREST AND WAS UNABLE TO BE RESUSCITATED DUE TO EMD ARRHYTHMIA AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN PROTACK FIXATION DEVICE GDW COVIDIEN UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death