BEUDAMED
    FDA Adverse Event Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2222763 · Received August 2, 2011

    Report

    Report Number
    1220423-2011-00024
    Date Received
    August 2, 2011
    Report Date
    July 25, 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

    MANUFACTURER'S COMMENT: THE RISK-BENEFIT RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT. JOURNAL: J. OF THE JAPANESE SOCIETY OF PEDIATRIC SURGEONS. AUTHOR: INOUE, M., ET AL. TITLE: CONSIDERATION REGARDING ADEQUACY TO ALL OF THE PEDIATRIC LAPARATOMY CASES WITH SEPRAFILM USE FROM THE VIEW POINT OF MEDICAL COST. YEAR: 2011. PAGES: 675.

    Description of Event or Problem · 1

    POSTOPERATIVE ADHESIVE INTESTINAL OBSTRUCTION [INTESTINAL OBSTRUCTION]. CASE DESCRIPTION: LITERATURE REPORT WAS RECEIVED ON (B)(4) 2011 FROM A PHYSICIAN REGARDING A CHILD, INITIALS UNKNOWN. THIS REPORT IS FROM A LITERATURE ARTICLE ENTITLED "CONSIDERATION REGARDING ADEQUACY TO ALL OF THE PEDIATRIC LAPARATOMY CASES WITH SEPRAFILM USE FROM THE VIEW POINT OF MEDICAL COST." THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE AFTER 2001, THE PATIENT HAD SEPRAFILM APPLIED. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED POSTOPERATIVE ADHESIVE INTESTINAL OBSTRUCTION. THE ACTION TAKEN WITH SEPRAFILM WAS NOT PROVIDED. THE PATIENT'S OUTCOME FOR THE EVENT WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENT WAS NOT PROVIDED BY THE REPORTING PHYSICIAN. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011. THE INFANT PATIENT HAD A LAPAROTOMY AND SEPRAFILM WAS USED.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other