BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 622804 · Received July 22, 2005

    Report

    Report Number
    1213643-2005-00125
    Event Type
    Death
    Date Received
    July 22, 2005
    Report Date
    June 22, 2005
    Manufacturer
    *
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MATERIAL FRACTURED IN THE AREA OF THE RIM OF THE PLASTIC REINFOREMENT, THE PENETRATION OCCURRED ON THE RIGHT SIDE TO THE COLON AND ON THE LEFT TO THE SMALL INTESTINE, LEADING TO A SEVERE PERITONITIS AND BOTH A COLONIC AND A SMALL INTESTINE FISTULA. DURING THE FURTHER PROCEEDINGS THISNET WAS ALSO EXPLANTED, INCLUDING THE TREATMENT OF A LAPAROSTOMA. AFTER TWO MONTHS OF INTENSIVE THERAPY, THE PATIENT HAS BEEN TRANSFERRED TO A SHORT TERM CARE INSTITUTION IN A CONDITION THAT REQUIRES A HIGH LEVEL OF CARE. THE COLONIC FISTULA AND SMALL INTESTINE FISTULA ARE STILL IN EXISTENCE. (IN A COMPLAINT INCIDENT REPORT OF 2005 THE DOCTOR PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: 1. IN-PATIENT TREATMENT FOR SEVERAL WEEKS, INCLUDING EXPLANTATION AND A NEW HERNIA. 2. INTENSIVE CARE FOR SEVERAL WEEKS WITH HERNIA. PATIENT DIED IN THE MEANTIME.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH-COMPOSIX KUGEL SURGICAL MESH FTL * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death