BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATRIUM C-QUR MESH 8" X 12"

    MDR report key: 1058158 · Received June 5, 2008

    Report

    Report Number
    1219977-2008-00004
    Event Type
    Other
    Date Received
    June 5, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 2, 2008
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS BEEN HAVING EPISODES OF ABDOMINAL PAIN WITH DISTENTION INDICATIVE OF PARTIAL BOWEL OBSTRUCTION FOR SOME TIME. PROCEDURES: EXPLORATORY LAPAROTOMY, EXTENSIVE LYSIS OF ADHESIONS, REMOVAL OF OLD MESH, INCISIONAL HERNIA REPAIR WITH MESH, BIOPSY OF PERITONEAL NODULE. PROCEDURE DETAILS: EXTENSIVE INTRA-ABDOMINAL ADHESIONS WERE NOTED. THE PREVIOUSLY PLACED MESH WAS NOTED TO BE SEVERELY CONTRACTED AND THICKENED. THERE WAS A DEFECT IN THE UPPER ABDOMEN RELATED TO A CURRENT HERNIA. THERE WAS DILATATION OF THE SMALL BOWEL LOOPS PROXIMALLY WITH DECOMPRESSED DISTAL BOWEL LOOPS. LYSIS OF ADHESIONS WAS DONE WITH DISSECTION OF THE SMALL BOWEL LOOPS. SEPRAFILM WAS PLACED IN THE PERITONEAL CAVITY TO LOWER THE CHANCE OF RECURRENCE OF THE ADHESIONS. PRIOR TO THE AFOREMENTIONED THERE WAS A SMALL NODULE MEASURING ABOUT 4 MM INVOLVED IN THE ADHESIONS; THIS WAS REMOVED AND WAS SENT FOR PATHOLOGICAL EVALUATION. EVALUATION RESULTS: PRODUCT WAS RECEIVED AND EVALUATED. ADDITIONAL INFORMATION RECEIVED FROM THE DOCTOR STATED 4 SUTURES WERE USED TO SECURE MESH. TYPICALLY FOR THIS SIZE MESH AND LOCATION, A GREATER NUMBER OF SUTURES SHOULD BE USED. THE LOT HISTORY RECORD WAS REVIEWED AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS. PROPER FIXATION IS CRITICAL IN THE REPAIR OF EPIGASTRIC/SUBCOSTAL HERNIAS, AND OUR EXAMINATION OF THE EXPLANT FROM THIS CASE INDICATES THE POTENTIAL FOR LESS THAN ADEQUATE FIXATION. THE "CONTRACTION AND THICKENING" SEEN AT EXPLANT WAS MOST LIKELY RELATED TO POOR FIXATION TECHNIQUE, WHICH CAUSED THE MESH TO "BUNCH UP" ON ITSELF AND BECOME ENCAPSULATED WITH TISSUE.

    Description of Event or Problem · 1

    HOSPITAL DESCRIPTION OF EVENT: IN 2007, A LARGE C-QUR MESH WAS USED FOR COVERING THREE DEFECT SITES: OSTOMY SITE IN THE RIGHT SIDE, ANOTHER WAS IN THE EPIGASTRIC AREA, AND THE OTHER WAS IN THE MIDLINE CLOSE TO THE UMBILICUS. THE MESH WAS PASSED INTO THE PERITONEAL CAVITY AFTER THE SUTURES WERE PLACED IN FOUR AREAS IN THE CIRCUMFERENCE OF THE MESH. SMALL INCISIONS WERE MADE IN THE ABDOMINAL WALL AFTER THE AREA WAS MARKED IN RELATION THE LOCATION OF THE DEFECTS AND THE MESH SIZE. THE SUTURES THAT WERE PLACED IN THE MESH WERE PASSED INTO THE ABDOMINAL WALL AND THEY WERE TIED. THERE WAS GOOD COVERAGE OF THE DEFECTS. THE MESH WAS FURTHER SECURED WITH A TACK THAT WAS PASSED THROUGH THE MESH INTO THE ABDOMINAL WALL. THE AREA WAS EXAMINED AND THERE WAS STOOD HEMOSTASIS WITH NO EVIDENCE OF BOWEL INJURY. IN 2008, THE PATIENT PRESENTED WITH RECURRENT ABDOMINAL BULGE IN THE UPPER ABDOMEN AFTER LAPAROSCOPIC REPAIR OF INCISIONAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRIUM C-QUR MESH 8" X 12" NONE FTL 10179101020C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention