BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2181086 · Received July 22, 2011

    Report

    Report Number
    1220423-2011-00022
    Event Type
    Injury
    Date Received
    July 22, 2011
    Report Date
    July 13, 2011
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: THE RISK-BENEFIT RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT. REPORT SOURCE LITERATURE DESCRIPTION - JOURNAL: PROGRAM OF 66TH SOCIETY OF JAPAN GASTROENTEROLOGICAL SURGERY SOCIETY. AUTHOR: MAKOTO TAKINAMI, JUN-ICHIRO HAGA, KAZUHIRO HADA. TITLE: ONE CASE OF ADHESIVE INTESTINAL OBSTRUCTION CAUSED BY SEPRAFILM. YEAR: 2011, PAGES: 689.

    Description of Event or Problem · 1

    ADHESIVE INTESTINAL OBSTRUCTION [INTESTINAL OBSTRUCTION]. CASE DESCRIPTION: LITERATURE REPORT WAS RECEIVED ON (B)(6) 2011 FROM A PHYSICIAN REGARDING AN (B)(6) FEMALE PT, INITIALS UNK. WITH PANCREATITIS ACUTE AND COLITIS ISCHAEMIC. THIS REPORT IS FROM A LITERATURE ARTICLE ENTITLED "ONE CASE OF ADHESIVE INTESTINAL OBSTRUCTION CAUSED BY SEPRAFILM", PROGRAM OF 66TH SOCIETY OF JAPAN GASTROENTEROLOGICAL SURGERY SOCIETY, (TAKINAMI, M., HAGA, J., AND HADA, K.). THE PT HAD THREE OPERATIONS DURING FOUR HOSPITALIZATIONS. POSTOPERATIVE DAY 58, AT HER LATEST HOSPITALIZATION/OPERATION SHE WAS ADMITTED DUE TO ABDOMINAL PAIN AND DISTENSION. SHE HAD BEEN UNDER CONSERVATORY CLINICAL OBSERVATION WITH FASTING THERAPY IN ORDER TO IMPROVE THE SYMPTOMS, BUT NO OBVIOUS IMPROVEMENT WAS OBSERVED. SHE HAD A LAPAROTOMY AT DAY 25 OF ADMISSION. SEPRAFILM HAD BEEN USED, ONE TO THE FORE SIDE OF MESENTERY PROPER AND ONE FOR UNDER INCISION AT THE LAST SURGERY. AT THE CORRECTIVE LAPAROTOMY, THERE WAS NO ADHESION UNDER THE INCISION. HOWEVER, SMALL INTESTINE WAS COVERED BY MEMBRANE LIKE WHITE SHINY OBJECT FROM THE LOCATION ABOUT 30 CM FROM LIGAMENT OF TREITZ TO THE SITE ABOUT 50 CM PROXIMAL TO ILEOCECAL VALVE, WHICH FORMED ONE MASS. INTESTINAL TRACT INSIDE OF THE MEMBRANE LIKE WHITE SHINY OBJECT WAS COMPRESSED LIKE CORNICE, BUT COMMUNICATION INSIDE OF THE TRACT WAS KEPT. IN ORDER TO PREVENT SHORT-BOWEL SYNDROME, SYNECHOTOMY WAS PRACTICED AS POSSIBLE AS THEY COULD, AND THE ONLY AREA WITH SEVERE ADHESION WAS RESECTED. IT WAS DIFFICULT TO DETACH SEROSAL MEMBRANE WITH THE MEMBRANE LIKE OBJECT EXISTING, HOWEVER THE ADHESION INSIDE OF THE INTESTINAL TRACTS WAS MILD. AFTER ANASTOMOSED, LENGTH OF RESIDUAL INTESTINAL TRACT WAS ABOUT 130 CM LONG. POSTOPERATIVE COURSE WAS FAVORABLE. PATHOLOGICAL HISTOLOGY DIAGNOSIS OF THE INTESTINAL TRACT WAS MEMBRANE AND MUSCLE LAYER WAS NORMAL, BUT SEROSAL MEMBRANE HAD INFLAMMATION. THERE EXISTED EQUABLE FIBROUS TISSUE OUTSIDE OF THE SEROSAL MEMBRANE AND NON-SPECIFIC TISSUE COMPONENT INSIDE OF IT. IN ORDER TO PREVENT ADHESION OF OMENTUM TO MESENTERIUM AND ADHESION BETWEEN ABDOMINAL WALL AND INTESTINAL TRACT, THE PT HAD TWO SHEETS OF SEPRAFILM WERE USED UPPER AND DOWN AREA RESPECTIVELY BETWEEN SMALL INTESTINAL TRACTS AT THE LATEST SURGERY. CONSEQUENTLY, SEPRAFILM, WRAPPED WIDE AREA OF INTESTINAL TRACT. IT WAS CONSIDERED THAT SEPRAFILM PREVENTED BOWEL PERISTALTIC MOTION BY PERSISTING, NOT BEING ABSORBED. THE ACTION TAKEN WITH SEPRAFILM WAS NOT PROVIDED. THE PT'S OUTCOME FOR THE ADHESIVE INTESTINAL OBSTRUCTION WAS RECOVERED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY OF THE EVENT ADHESIVE INTESTINAL OBSTRUCTION WAS NOT PROVIDED. THE REPORTING AUTHOR ASSESSED THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENT OF ADHESIVE INTESTINAL OBSTRUCTION AS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE BIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY (SEPRAFILM/PACK) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization