BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2898397 · Received January 2, 2013

    Report

    Report Number
    1220423-2013-00002
    Event Type
    Other
    Date Received
    January 2, 2013
    Report Date
    December 26, 2012
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    PMA P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT. REPORT SOURCE LITERATURE DESCRIPTION: JOURNAL: JAPAN SURGERY INFECTION SOCIETY MAGAZINE, AUTHOR: HANAOKA T, MORI M, HANARI N ET AL, TITLE: THREE CASES IN WHICH SEPRAFILM PRESENTED THE STOMACH CANCER POSTOPERATIVE INTRAABDOMINAL ABSCESS CONSIDERED TO BE THE CAUSE. VOLUME: 9 (5). YEAR: 2012, PAGES: 597.

    Description of Event or Problem · 1

    INTRA-ABDOMINAL ABSCESS [ABDOMINAL ABSCESS]. CASE DESCRIPTION: LITERATURE-SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM AN AUTHOR REGARDING A MALE PATIENT IN HIS 70'S, INITIALS UNKNOWN, WITH ADVANCED GASTRIC CANCER. THIS REPORT IS FROM A LITERATURE ARTICLE ENTITLED "THREE CASES IN WHICH SEPRAFILM PRESENTED THE STOMACH CANCER POSTOPERATIVE INTRAABDOMINAL ABSCESS CONSIDERED TO BE THE CAUSE." THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR TONGUE CANCER. ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT ABDOMINAL DISTAL GASTRECTOMY WITH BILLROTH-I RECONSTRUCTION FOR ADVANCED GASTRIC CANCER AND SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) WAS PLACED (NUMBER OF SHEETS NOT PROVIDED). THE LOT NUMBER FOR SEPRAFILM WAS NOT PROVIDED. ON POST-OPERATIVE DAY 6, NEITHER ANASTOMOTIC STENOSIS NOR RUPTURED SUTURE WAS SHOWN ON UPPER GASTROINTESTINAL BY X-RAY WITH CONTRAST DYE. ON POST-OPERATIVE DAY 9, THE PATIENT DEVELOPED PYREXIA OF 39 DEGREE CELSIUS. ON AN UNSPECIFIED DATE, THE PATIENT'S BLOOD TEST REVEALED WHITE BLOOD CELL COUNT OF 13500 (UNITS NOT PROVIDED) AND C-REACTIVE PROTEIN VALUE OF 20 (UNITS NOT PROVIDED) WHICH FURTHER INDICATED STAGE 6 INFLAMMATION. COMPUTED TOMOGRAPHY REVEALED EFFUSION LOCALIZED JUST UNDER THE ABDOMINAL WALL, WHICH RESULTED IN DIAGNOSIS OF INTRA-ABDOMINAL ABSCESS. AN OPEN DRAINAGE WAS PERFORMED. THE CULTURE OF THE PUS REVEALED SMALL NUMBER OF BACTERIA. THE FOLLOW-UP COURSE WAS SATISFACTORY AFTER THE DRAINAGE AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON POST-OPERATIVE DAY 18. THE OUTCOME FOR THE EVENT OF INTRA-ABDOMINAL ABSCESS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF INTRA-ABDOMINAL ABSCESS WAS NOT PROVIDED. IN THE OPINION OF THE AUTHOR, SEPRAFILM WAS CONSIDERED TO BE THE CAUSE OF POSTOPERATIVE INTRAABDOMINAL ABSCESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention