BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2625769 · Received June 13, 2012

    Report

    Report Number
    1220423-2012-00021
    Event Type
    Other
    Date Received
    June 13, 2012
    Report Date
    June 5, 2012
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT REQUIRED A SECOND ENTEROTOMY TO REPAIR SMALL BOWEL LEAK [GASTROINTESTINAL ANASTOMOTIC LEAK]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2012, FROM A PHYSICIAN, VIA A COMPANY REPRESENTATIVE, REGARDING A (B)(6) MALE PATIENT, INITIALS UNKNOWN. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ULCERATIVE COLITIS (POSSIBLY CROHN'S DISEASE) AND FISTULA. ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT SURGERY FOR A FISTULA REPAIR WHERE SEPRAFILM WAS PLACED OVER THE SMALL BOWEL, NUMBER OF SHEETS NOT PROVIDED. FOUR DAYS POST-OPERATIVE, THE PATIENT REQUIRED A SECOND ENTEROTOMY TO REPAIR A SMALL BOWEL LEAK. THE PHYSICIAN MENTIONED THAT HE FOUND THE SEPRAFILM IMPOSSIBLE TO SEPARATE THE SMALL BOWEL LOOPS, DUE TO SEPRAFILM CONSISTENCY. WHEN DISCUSSING THE SEPRAFILM PROPERTIES TO THE COMPANY REPRESENTATIVE, THE PHYSICIAN DESCRIBED THE SEPRAFILM AS BEING DIFFERENT FROM THE EXPECTED CONSISTENCY; AS BEING BETWEEN DEHYDRATED AND HYDRATED SEPRAFILM. THE HCP WAS EVENTUALLY ABLE TO COMPLETE THE SURGERY BY WORKING FROM THE OPPOSITE SIDE OF THE SMALL BOWEL. THE ACTION TAKEN WITH SEPRAFILM TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF SMALL BOWEL LEAKAGE WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF SMALL BOWEL LEAK WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENT OF SMALL BOWEL LEAK WAS NOT PROVIDED BY THE REPORTING PHYSICIAN.

    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 30 YR Required Intervention