BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2213996 · Received June 23, 2011

    Report

    Report Number
    1220423-2011-00019
    Event Type
    Other
    Date Received
    June 23, 2011
    Report Date
    June 16, 2011
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MFR'S CONTROL NUMBER (B)(4) FOR OTHER ADVERSE EVENTS FROM THIS REPORTER. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    BOWEL OBSTRUCTION [INTESTINAL OBSTRUCTION]. PERITONEAL PERITONITIS [PERITONITIS]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2011, FROM A PHYSICIAN VIA A COMPANY SALES REPRESENTATIVE REGARDING A PT, INITIALS NOT PROVIDED. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT HAD AN UNSPECIFIED SURGERY DURING WHICH SEPRAFILM, LOT NUMBER UNKNOWN, WAS APPLIED. ON AN UNKNOWN DATE, THE PT HAD A SURGICAL REOPERATION FOR BOWEL OBSTRUCTION AND PERITONEAL PERITONITIS. LOCATION OF EVENT, PAST SURGICAL HISTORY, ALLERGIES, AND EXPOSURE DURING SURGERY WERE ALL UNKNOWN. THE ACTION TAKEN WITH SEPRAFILM WAS NOT PROVIDED. THE PT'S OUTCOME FOR THE EVENT WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENTS OF BOWEL OBSTRUCTION AND PERITONEAL PERITONITIS AS DEFINITELY 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 UNK Required Intervention