BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2904626 · Received January 3, 2013

    Report

    Report Number
    1220423-2013-00003
    Event Type
    Other
    Date Received
    January 3, 2013
    Report Date
    December 26, 2012
    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

    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, 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 70'S, INITIALS UNKNOWN, WITH GASTRIC REMNANT CANCER (M-4-S). THIS REPORT WAS FROM A LITERATURE ARTICLE ENTITLED "THREE CASES IN WHICH SEPRAFILM PRESENTED THE STOMACH CANCER POSTOPERATIVE INTRA ABDOMINAL ABSCESS CONSIDERED TO BE THE CAUSE". ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT TOTAL RESECTION OF GASTRIC REMNANT WITH ROUX-EN-Y RECONSTRUCTION AND SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE WAS PLACED (NUMBER OF SHEETS NOT PROVIDED). THE LOT NUMBER OF SEPRAFILM WAS NOT PROVIDED. ON POSTOPERATIVE DAY 07, SURGICAL SITE INFECTION WAS DIAGNOSED. THE AMOUNT OF EFFUSION FROM THE INCISION SITE INCREASED MORE. ON POSTOPERATIVE DAY 10, AN OPEN DRAINAGE WAS PERFORMED. THE CULTURE OF THE PUS REVEALED STAPHYLOCOCCUS SPECIES. COMPUTED TOMOGRAPHY PERFORMED AFTER THE DRAINAGE REVEALED CAVITY COMMUNICATING FROM INTRA-ABDOMINAL TO SUBCUTANEOUS, WHICH RESULTED IN DIAGNOSIS OF INTRA-ABDOMINAL ABSCESS. SUBSEQUENTLY, FRAGMENTS OF SEPRAFILM WERE DRAINED FROM INSIDE OF THE ABDOMEN. THE FOLLOW-UP WAS SATISFACTORY AFTER THE DRAINAGE AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON POSTOPERATIVE DAY 19. 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 INTRA-ABDOMINAL ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3553 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