BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM ADHESION BARRIER

    MDR report key: 513621 · Received February 25, 2004

    Report

    Report Number
    1220423-2004-00001
    Event Type
    Injury
    Date Received
    February 25, 2004
    Date of Event
    November 24, 2003
    Report Date
    February 25, 2004
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MCN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    INFLAMMATORY FOREIGN BODY REACTION. INFORMATION WAS RECEIVED FROM A SURGEON IN 2004 REGARDING A PATIENT (INITIALS AND AGE NOT PROVIDED) WITH A HISTORY OF RECTAL CANCER AND PRIOR "OB-GYN SURGERIES." THE PATIENT UNDERWENT LOWER ANTERIOR RESECTION WITH PRIMARY ANASTOMOSIS FOR RECTAL CANCER IN 2003. UPON OPERATION, THE PATIENT WAS FOUND TO HAVE A FEW ADHESIONS FROM PREVIOUS PROCEDURES. THE PATIENT RECEIVED ONE SHEET OF SEPRAFILM UNDER IN THE INCISION AND WAS CLOSED WITH #1 PDS RUN, WITH SKIN STAPLES. THE PATIENT DEVELOPED NAUSEA, VOMITING, AND ABDOMINAL PAIN THREE TO FOUR DAYS AFTER SURGERY. THE PATIENT WAS TREATED WITH NASOGASTRIC SUCTION AND IV FLUID SUPPORT. BUT THIS DID NOT RELIEVE THEIR SYMPTOMS OF THE SMALL BOWEL OBSTRUCTION. THE PATIENT WAS RE-OPERATED 11 DAYS LATER AND WAS FOUND TO HAVE MASSIVE ADHESIONS WITH THREE TO FOUR LOOPS OF SMALL BOWEL "TENACIOUSLY PULLED IN", VERY TIGHT AND CONCRETE, ALL LOCAL TO THE AREA WHERE THE SEPRAFILM HAD BEEN PLACED. A BIOPSY WAS PERFORMED ON THE ADHESIONS, WHICH SHOWED FOREIGN BODY, GIANT CELLS, BUT ALCIAN BLUE STAINING OR HYALURONIDASE DIGESTION WAS NOT PERFORMED ON THE SPECIMEN. THE SURGEON DIAGNOSED THIS PATIENT'S SYMPTOMS AS AN INFLAMMATORY FOREIGN BODY REACTION TO SEPRAFILLM. ALTHOUGH THE SURGEON DID NOT SPECIFICALLY PROVIDE A RELATIONSHIP BETWEEN THE EVENT AND SEPRAFILM, THE SURGEON DID PROVIDE THAT HE FELT THIS WAS A FOREIGN BODY REACTION TO SEPRAFILM IMPLYING A POSSIBLE CAUSAL RELATIONSHIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R