BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2612720 · Received June 1, 2012

    Report

    Report Number
    1220423-2012-00020
    Event Type
    Other
    Date Received
    June 1, 2012
    Report Date
    May 25, 2012
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SMALL BOWEL OBSTRUCTION [SMALL INTESTINAL OBSTRUCTION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A PHYSICIAN (VIA A COMPANY REP) REGARDING A PT (INITIALS, GENDER AND DATE OF BIRTH NOT PROVIDED). THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT UNDERWENT ABDOMINAL SURGERY (TYPE NOT PROVIDED) DURING WHICH SEPRAFILM WAS PLACED. TEN DAYS POST-ABDOMINAL SURGERY AND THE PLACEMENT OF SEPRAFILM, THE PT EXPERIENCED SMALL BOWEL OBSTRUCTION WHERE THE PHYSICIAN HAD TO PERFORM A SECOND PROCEDURE TO TREAT THE SMALL BOWEL OBSTRUCTION. THE ACTION TAKEN WITH SEPRAFILM TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF SMALL BOWEL OBSTRUCTION WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF SMALL BOWEL OBSTRUCTION WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENT OF SMALL BOWEL OBSTRUCTION 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention