BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMESH

    MDR report key: 1422952 · Received July 27, 2009

    Report

    Report Number
    3003936139-2009-00004
    Event Type
    Injury
    Date Received
    July 27, 2009
    Report Date
    July 27, 2007
    Manufacturer
    GFE MEDIZINTECHNIK GMBH
    Product Code
    FTL
    PMA / PMN Number
    K031225
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS RECENTLY DISCOVERED THAT THIS CASE HAS NOT BEEN APPROPRIATELY REPORTED. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED IMMEDIATELY AFTER RECEPTION OF THE MESSAGE (DATED 11-10-2006); THE BATCH MET ALL CRITERIA FOR THE RELEASE OF FINISHED PRODUCTS. A SECOND REVIEW OF THE DHR AND RETAINED SAMPLES WERE CARRIED OUT PRIOR TO THIS MDE (SEE ANNEX 1 AND 2). CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL FORM WILL BE SUBMITTED ACCORDINGLY. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE PATIENT WAS OPERATED ON FOR A SMALL INCISIONAL HERNIA THROUGH A LAPAROSCOPIC APPROACH USING A 4"X6" TIMESH. DURING THE PROCEDURE, THERE WERE NO DENSE ADHESIONS OF THE BOWEL TO THE HERNIA DEFECT OR SAC. THE TIMESH WAS FIXED INTO PLACE WITH CORNER SUTURES OF ABSORBABLE VICRYL AND THEN THE REMAINDER OF THE FIXATION WAS DONE WITH A Q RING TACKING DEVICE IN A CORONAL PATTERN AROUND THE EDGE OF THE MESH. AT APPROXIMATELY 5 DAYS POST OP, THE PATIENT PRESENTED TO THE EMERGENCY ROOM AT A DIFFERENT HOSPITAL AND WAS SEEN BY DR. THE PATIENT WAS WORKED UP AND FOUND TO HAVE A SMALL BOWEL OBSTRUCTION, AND WAS TAKEN TO THE OPERATING ROOM AT APPROXIMATELY THE SEVENTH POST OPERATIVE DAY. INTRAOPERATIVELY, THE PATIENT WAS FOUND TO HAVE THE ENTIRE SURFACE OF THE MESH COVERED WITH DENSE ADHESIONS TO THE SMALL BOWEL WITH A TWISTING OF THE BOWEL, CAUSING A BOWEL OBSTRUCTION. THE ADHESIONS WERE VERY DENSE AND REQUIRED A SHARP ENTEROLYSIS AND A SMALL BOWEL RESECTION OF APPROXIMATELY 18" TO 24" AND A PRIMARY ANASTOMOSIS. DURING THE PROCEDURE, THERE WAS NO EVIDENCE OF AN ABSCESS, HEMATOMA, SEROMA OR SMALL BOWEL LEAK. THE ORIGINAL HERNIA WAS ABLE TO BE REPAIRED WITH A PRIMARY CLOSURE. POST OPERATIVELY, THE PATIENT HAS CONTINUED TO HAVE PAIN AND COMPLAINTS RELATED TO MALABSORPTION. THE POSSIBLE CAUSES OF THIS EVENT ARE NOT KNOWN. QUESTIONS ARE FAILURE OF THE TIMESH TO PREVENT ADHESIONS TO THE BOWEL IN THIS CASE. THE PRODUCT LOT NUMBER HAS BEEN TRACED AND THERE HAVE BEEN NO OTHER PROBLEMS RELATED TO ANY OTHER ITEMS IN THIS BATCH, THEREBY ELIMINATING THE POSSIBILITY OF A DEFECTIVE BATCH. THE USE OF AN ABSORBABLE SUTURE TO ANCHOR THE CORNERS OF THE MESH SHOULD NOT HAVE CAUSED ADHESIONS OVER THE ENTIRE UNDERSURFACE OF THE MESH. LIKEWISE, THE Q RING TACKING DEVICE COULD POSSIBLY CAUSE SOME ADHESIONS, BUT NOT TO THE ENTIRE UNDERSURFACE OF THE MESH. WE WILL CONTINUE TO MONITOR FUTURE EVENTS TO MAKE SURE THAT A PATTERN DOES NOT ARISE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMESH SURGICAL MESH, FTL FTL GFE MEDIZINTECHNIK GMBH 6000138 10457

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization