BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM ADHESION BARRIER

    MDR report key: 565473 · Received January 10, 2005

    Report

    Report Number
    1220423-2005-00001
    Event Type
    Injury
    Date Received
    January 10, 2005
    Date of Event
    October 7, 2004
    Report Date
    January 10, 2005
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    MCN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS REPORT RECEIVED IN DECEMBER 2004 FROM A PHYSICIAN REGARDING A PT WHO UNDERWENT A GASTRECTOMY SUBTOTAL AND RIGHT HEMICOLECTOMY FOR GASTRIC CANCER AND LARGE INTESTINE CARCINOMA IN SEPTEMBER 2004 AT WHICH TIME ONE SHEET OF SEPRAFILM WAS PLACED UNDER THE INCISION AT THE ABDOMEN TO REDUCE THE SEVERITY AND EXTENT OF POST-OPERATIVE ADHESIONS. THERE WAS NO INFECTION AT THE SITE OF PLACEMENT, AND NO PLACEMENT OF SEPRAFILM ON ANASTOMOTIC PARTS. A MULTIDRAIN WAS PLACED TO THE RIGHT OF THE ABDOMEN. THE ABDOMINAL AREA WAS WASHED WITH ABDOMEN. THE ABDOMINAL AREA WAS WASHED WITH SIX LITERS OF WATER AND THE AREA WAS WITHOUT A NON-PURULENT INFLAMMATION OR EXISTING INFECTION AT THE TIME. A MANUAL ANASTOMOSIS OF THE STOMACH AREA AND COLON WAS PRACTICED WITH 3-0 VICRYL (POLYGLACTIN SYNTHETIC POLYMER SUTURE) FOR THE INTERNAL LAYER AND 3-0 BLACK SILK SUTURE FOR THE EXTERNAL LAYER. THE INCISION WAS 30CM LONG WITH THE PERITONEUM LAYER SUTURED VIA KNOTTING AND THE SKIN LAYER WAS DONE MANUALLY. THE PT'S MEDICAL HISTORY IS ADDITIONALLY REMARKABLE FOR ANEMIA, STATUS POST APPENDECTOMY, STATUS POST CHOLELITHOTRIPSY, HYPERTENSION, ANGINA PECTORIS, AND DIABETES MELLITUS. IN OCTOBER 2004, A POST-OPERATIVE VISIT REVEALED NO RUPTURED SUTURE, THE DRAIN WAS REMOVED, AND THE PT BEGAN ORAL INGESTION. THE NEXT DAY THE PT HAD A FEVER AND AN INTRAABDOMINAL ABSCESS WAS INITIALLY SUSPECTED. AN ABDOMINAL COMPUTED TOMOGRAPHY REVEALED A LIFE THREATENING ANASTOMOTIC LEAK WITH NON-SERIOUS ASCITES RETENTION UNDER THE ABDOMINAL WALL AT THE UMBILICAL AREA. BOTH EVENTS WERE MODERATE IN INTENSITY. A BIOPSY REVEALED NO SEROUS OPACITY AND CULTURES DID NOT REVEAL BACTERIAL GROWTH. TWO DAYS LATER THE PT HAD A RUPTURED SUTURE. THE PT WAS TREATED WITH INTRAVENOUS HYPERALIMENTATION. THE PT'S WHITE BLOOD CELL COUNT WAS 9,200CELLS/L AND C-REACTIVE PROTEIN LEVEL WAS 11.33MG/L. THE PT'S FEVER IMPROVED AND THE FLUID RETENTION RESOLVED. THE PT'S RUPTURED SUTURE RESOLVED IN NOVEMBER 2004. THE PT WAS DISCHARGED IN NOVEMBER 2004 AND RECOVERED COMPLETELY IN DECEMBER 2004. CONCOMITANT MEDICATIONS INCLUDED NIFEDIPINE, BETAXOLOL HYDROCHLORIDE, CANDESARTAN CILEXETIL, ACARBOSE, AND SODIUM FERROUS CITRATE. IT WAS THE OPINION OF THE PHYSICIAN THAT THE EVENT OF ANASTOMOTIC LEAK WAS UNRELATED TO SEPRAFILM AND THE EVENT OF ASCITES RETENTION WAS PROBABLY RELATED TO SEPRAFILM AS THE ASCITES WENT INTO THE AREA BETWEEN THE ABDOMINAL CAVITY AND SEPRAFILM WHICH DID NOT ALLOW FOR THE SEPRAFILM TO DISSOLVE AND INDUCED POOLING OF FLUID. CONCLUSIONS: NO SAMPLE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED BY THE USER FACILITY. GENZYME QUALITY ASSURANCE IS UNABLE TO PERFORM AN EVALUATION OR LOT HISTORY REVIEW. IF A LOT NUMBER IS PROVIDED IN THE FUTURE, THIS COMPLAINT WILL BE RE-EVALUATED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPRAFILM ADHESION BARRIER RESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening