BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD COMPOSIX KUGEL HERNIA PATCH

    MDR report key: 433851 · Received December 19, 2002

    Report

    Report Number
    MW1027020
    Event Type
    Injury
    Date Received
    December 19, 2002
    Date of Event
    October 6, 2002
    Report Date
    December 3, 2002
    Manufacturer
    DAVOL, INC.
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A LARGE VENTRAL HERNIA THAT WAS REPAIRED BY PLACEMENT OF A BARD COMPOSIX KUGEL HERNIA PATCH MEASURING 10"X13", OVAL, LOT #41AMDD10, REFERENCE NUMBER 0010207. THE PT DEVELOPED A WOUND INFECTION AND WAS BEING TREATED WITH WET TO DRY DRESSINGS AT HOME. FIVE MONTHS LATER, THE PT PRESENTED WITH AN ENTEROCUTANEOUS FISTULA, WITH SMALL BOWEL CONTENTS CONTAMINATING THE MESH. AFTER NUTRITIONAL SUPPORT, THE PT WAS TAKEN TO THE OPERATING ROOM WHERE THE INFECTED MESH WAS REMOVED. AT THAT TIME, A SMALL BUCKLE IN THE EDGE OF THE MESH THAT WAS SEWN TO THE ABDOMINAL WALL WAS NOTED. THIS BUCKLING CAUSED A PROTRUSION OF THE PTFE PORTION OF THE MESH INWARD TOWARDS THE ABDOMINAL CAVITY. THIS PROTRUSION WAS VERY SHARP AND EXTENDED ONLY ABOUT 5MM INTO THE ABDOMINAL CAVITY. HOWEVER, IT WAS ADJACENT TO A LOOP OF BOWEL WHICH WAS THE SITE OF THE ENTEROCUTANEOUS FISTULA. IT IS RPTR'S OPINION THAT THIS SMALL BUCKLING AND PROTRUSION OF THE PTFE PORTION OF THE MESH LED DIRECTLY TO INJURY TO THE SMALL BOWEL AND FISTULA. THE REMAINING PORTION OF THE MESH DEMONSTRATED NO BUCKLING AND THERE WERE NO OTHER ABNORMALITIES NOTED. THE PT HAD A LOOP ILEOSTOMY CREATED AND HAS DONE WELL POST-OPERATIVELY. HOWEVER, PT'S POST-OP COURSE HAS BEEN PROLONGED REQUIRING INPATIENT CARE UNTIL 12/02 AND A PLANNED NURSING HOME STAY PRIOR TO A PLANNED TAKE DOWN OF PT'S OSTOMY. A VICRYL MESH WAS USED TO REPAIR THE DEFECT LEFT BY THE COMPOSIX MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD COMPOSIX KUGEL HERNIA PATCH COMBINED MARLEX AND PTFE PATCH FOR ABDOMINAL WALL HERNIAS. FTM DAVOL, INC. REF. # 0010207 *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization