BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOS) MEMBRANE

    MDR report key: 3020649 · Received March 20, 2013

    Report

    Report Number
    1220423-2013-00009
    Event Type
    Other
    Date Received
    March 20, 2013
    Report Date
    March 11, 2013
    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

    REPORT SOURCE LITERATURE DESCRIPTION. JOURNAL: THE JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH; AUTHOR: WAGATSUMA S, YOKOYAMA T, SAKURADA N, MATSUMODO D. HOSHIAI T; TITLE: A CASE OF CHEMICAL PERITONITIS PROBABLY CAUSED BY ADHESION BARRIER (SEPRAFILM); VOLUME: 65, ISSUE 2, PAGES 730 (S-518). MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    CHEMICAL PERITONITIS [CHEMICAL PERITONITIS]. CASE DESCRIPTION: LITERATURE-SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM AN AUTHOR REGARDING A (B)(6) FEMALE PT, INITIALS UNK. THIS REPORT WAS FROM A LITERATURE ARTICLE ENTITLED "A CASE OF CHEMICAL PERITONITIS PROBABLY CAUSED BY ADHESION BARRIER (SEPRAFILM)". THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR CERVIX CARCINOMA (STAGE I1 1). ON AN UNSPECIFIED DATE, THE PT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT PANHYSTERECTOMY WITH BILATERAL ADNEXAL RESECTION AND SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) WAS PLACED ON THE PELVIC FLOOR PERITONEUM (NUMBER OF SHEETS NOT PROVIDED) INSTEAD OF SUTURE. THE LOT NUMBER OF SEPRAFILM WAS NOT PROVIDED. THE PT WAS DISCHARGED ON THE SEVENTH POST-OPERATIVE DAY. ON AROUND THE TENTH POST OPERATIVE DAY, ABDOMINAL BLOATING WAS DEVELOPED. ON THE POST OPERATIVE 13TH DAY, THE PT WAS PRESENTED TO THE OUTPUT CLINIC AND TENDERNESS WAS OBSERVED IN THE WHOLE ABDOMEN. ON AN UNSPECIFIED DATE, BASED ON COMPUTED TOMOGRAPHY (CT) FINDINGS THE PT WAS DIAGNOSED AS HAVING PARALYTIC INTESTINAL OBSTRUCTION CAUSED BY PERITONITIS AND WAS STATED ON TREATMENT WITH MEROPENEM. ON POST-OPERATIVE DAY 16, SHE UNDERWENT DRAINAGE WITH LAPAROTOMY BECAUSE CT SCAN RESULTS SUGGESTED EXACERBATION OF PERITONITIS, ALTHOUGH THERE WAS A MILD IMPROVEMENT IN INFLAMMATORY REACTION. LAPAROTOMY FINDINGS REVEALED MASSIVE YELLOW ASCITES WITH EXTENSIVE INTESTINAL ADHESIONS, OF WHICH THE PELVIC ADHESION WAS MOST ADVANCED. THE PT RECEIVED REMOVAL OF MOSS ATTACHED TO THE INTESTINAL SERIOUS MEMBRANE AND THE PELVIC FLOOR. THERE WERE NO FINDINGS THAT CLEARLY SUGGESTED INFECTIONS INCLUDING ABSCESS. ASCITIC BACTERIAL CULTURE WAS NEGATIVE WHILE THE WHITE MOSS WAS HISTOPATHOLOGICALLY FOUND TO BE INFLAMMATORY ALTERED FIBRIN CLOTS CONTAINING A NUMBER OF NEUTROPHILS AND HISTIOCYTES. NO BACTERIA WERE DETECTED ON GRAM'S STAIN. BASED ON THESE FINDINGS, THE PT WAS DIAGNOSED WITH SEPRAFILM-RELATED CHEMICAL PERITONITIS AND SUBSEQUENTLY SHE WAS STARTED ON ORAL PREDONINE (PREDNISOLONE) AFTER THE SECOND SURGERY. ON AN UNSPECIFIED DATE, THE CHEMICAL PERITONITIS RESOLVED RESULTING IN DISCHARGE 18 DAYS AFTER THE SECOND SURGERY. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENT WAS NOT PROVIDED BY THE REPORTING AUTHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116786 SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOS) MEMBRANE BIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY (SEPRAFILM/PACK) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention