BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 1335874 · Received March 5, 2009

    Report

    Report Number
    1220423-2009-00012
    Event Type
    Other
    Date Received
    March 5, 2009
    Report Date
    February 19, 2009
    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. JOURNAL: GYNECOL ONCOL. AUTHOR: LEITAO JR MM, NATENZON A, ABU-RUSTUM NR, BROWN C, CHI DS, SONODA Y, LEVINE DA, GARDNER GJ, BARAKAT RR. TITLE: POSTOPERATIVE INTRA-ABDOMINAL COLLECTIONS USING A SODIUM HYALURONATE-CARBOXYMETHYLCELLULOSE BARRIER (HA-CMC) AT THE TIME OF LAPAROTOMY FOR OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCERS. VOLUME: 112; YEAR: 2009; PAGES: 2; SUPPL 1. EVALUATION SUMMARY. NO SAMPLE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED BY THE USER FACILITY, THEREFORE, GENZYME QUALITY ASSURANCE IS UNABLE TO PERFORM AN EVALUATION OR LOT HISTORY REVIEW. IF A LOT NUMBER IS PROVIDED IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED AND THE APPROPRIATE INVESTIGATION WILL BE CONDUCTED. CONCLUSIONS: HA-CMC APPEARS TO BE ASSOCIATED WITH A DIAGNOSIS OF POSTOPERATIVE INTRA-ABDOMINAL COLLECTIONS WITHOUT A REDUCTION IN THE RATE OF POSTOPERATIVE ILEUS OR SMALL BOWEL OBSTRUCTION IN PATIENTS UNDERGOING DEBULKING.

    Description of Event or Problem · 1

    INTRA-ABDOMINAL FLUID COLLECTION [LOCALISED INTRAABDOMINAL FLUID COLLECTION]. CASE DESCRIPTION: LITERATURE-SPONT REPORT RECEIVED ON 19-FEB-2009 FROM A COMPANY REPRESENTATIVE REGARDING A FEMALE PATIENT OF UNKNOWN AGE AND INITIALS, WHOSE RELEVANT MEDICAL HISTORY INCLUDED CANCER. THIS REPORT WAS RECEIVED FROM A LITERATURE ARTICLE ENTITLED "POSTOPERATIVE INTRA-ABDOMINAL COLLECTIONS USING A SODIUM HYALURONATE-CARBOXYMETHYLCELLULOSE BARRIER (HA-CMC) AT THE TIME OF LAPAROTOMY FOR OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCERS". ON AN UNKNOWN DATE, THE PATIENT RECEIVED AN UNKNOWN NUMBER OF SHEETS OF SEPRAFILM DURING A LAPAROTOMY PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED INTRA-ABDOMINAL FLUID COLLECTION WHICH REQUIRED DRAINAGE. IT WAS THE OPINION OF THE PHYSICIAN THAT THE SEPRAFILM WAS ASSOCIATED WITH THE DIAGNOSIS OF POST-OPERATIVE ABDOMINAL COLLECTION. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PATIENT OUTCOME WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. (B)(4).

    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 Required Intervention