BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM BIORESORBABLE MEMBRANE

    MDR report key: 289334 · Received August 10, 2000

    Report

    Report Number
    1220423-2000-00028
    Event Type
    Injury
    Date Received
    August 10, 2000
    Date of Event
    July 14, 2000
    Report Date
    August 9, 2000
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MCN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS). THE PT IS OBESE. PT PREVIOUSLY UNDERWENT A RIGHT HEMI-COLECTOMY WITH ILEOSTOMY AND REPAIR OF INCISIONAL HERNIA IN 2000 FOR MESENTERIC ISCHEMIA. IN 2000, PT EXPERIENCED INCREASED WBC, ACIDOSIS, AND ELEVATED LACTATE LEVELS. PT WAS TAKEN BACK TO THE OPERATING ROOM FOR AN OSTOMY REVISION AND PLACEMENT OF RETENTION SUTURES. PT'S POSTOPERATIVE DIAGNOSIS WAS ISCHEMIC ILEOSTOMY, PERFORATED ILEOSTOMY, AND PARTIAL FASCIAL DEHISCENCE. THE PT DID WELL AND WAS DISCHARGED HOME. ON JULY 13, 2000, PT UNDERWENT ILEOSTOMY CLOSURE WITH RESECTION OF SMALL AND LARGE INTESTINES AND REPAIR OF INCISIONAL HERNIA, AND WAS ENROLLED IN A STUDY (ID# 100602, KEF). INTRAOPERATIVELY, THE PT WAS NOTED TO HAVE SEVERE DENSE ADHESIONS, WHICH INVOLVED THE SMALL BOWEL TO SMALL BOWEL, SMALL BOWEL TO SIGMOID COLON, SMALL BOWEL TO ANTERIOR AND RIGHT ABDOMINAL WALL. NO ENTEROTOMIES WERE PERFORMED PRIOR TO CLOSURE. TEN SHEETS OF SEPRAFILM WERE PLACED IN THE RIGHT ABDOMINAL SIDEWALL OVER SIGMOID AND DESCENDING COLON BETWEEN SMALL BOWEL LOOPS AND BETWEEN SMALL BOWEL AND ANTERIOR ABDOMINAL WALL. WITHIN 24 HOURS, POSTOPERATIVE COURSE BECAME COMPLICATED BY SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS) WITH TACHYCARDIA, HYPOTENSION, ACIDOSIS, AND RISING LACTATE. PT DID HAVE SOME SEROSANGUINOUS DRAINAGE NOTED FROM THE WOUND IN THE EARLY A.M., WHICH WAS CONTROLLED BY TIGHTENING PATIENT'S RETENTION SUTURES SLIGHTLY. DUE TO PT'S RISING LACTATE, PT WAS TAKEN BACK TO THE OPERATING ROOM IN 2000 FOR EXPLORATORY LAPAROTOMY. NO ISCHEMIC BOWEL WAS NOTED. THERE WAS NO EVIDENCE OF INTENSE PERITONITIS. THE ANASTOMOSIS WAS WITHOUT EVIDENCE OF A LEAK. THE SEPRAFILM WAS WASHED OUT WITH APPROXIMATELY 6 LITERS OF WARM ANTIBIOTICS. PERITONEAL FLUID WAS CULTURED AND EVENTUALLY GREW OUT VANCOMYCIN RESISTANT ENTEROCOCCUS. DURING THE PROCEDURE, THE PT BECAME MUCH LESS TACHYCARDIC AND PATIENT'S BLOOD PRESSURE IMPROVED. THE PT WAS DISCHARGED TO HOME IN 2000. THE REPORTING PHYSICIAN ASSESSED THE EVENT AS POSSIBLY RELATED TO THE USE OF SEPRAFILM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPRAFILM BIORESORBABLE MEMBRANE RESORBABLE ADHESION BARRIER MCN GENZYME CORPORATION NA 389426

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention