BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2496700 · Received March 15, 2012

    Report

    Report Number
    1220423-2012-00006
    Event Type
    Other
    Date Received
    March 15, 2012
    Report Date
    March 6, 2012
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    MULTIPLE ABSCESSES [ABSCESS]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012, FROM A PHYSICIAN VIA A SALES REPRESENTATIVE, REGARDING A FEMALE PATIENT, (INITIALS AND DATE OF BIRTH UNKNOWN) UNDERGOING A CESAREAN SECTION. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PHYSICIAN CUT A SHEET OF SEPRAFILM INTO TWO PIECES. THE PHYSICIAN DIPPED THE CUT SHEETS IN SALINE TO HELP HIM MOLD THE FILM. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED AN INFECTION WITH MULTIPLE ABSCESSES. ON AN UNSPECIFIED DATE, ALL CULTURES CAME BACK NEGATIVE. THE PHYSICIAN REPORTED THAT THE PATIENT ENDED UP REQUIRING A HYSTERECTOMY. THE ACTION TAKEN WITH SEPRAFILM TREATMENT WAS NOT PROVIDED. THE OUTCOMES FOR THE EVENT OF MULTIPLE ABSCESSES WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF MULTIPLE ABSCESSES WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENT OF MULTIPLE ABSCESSES WERE NOT PROVIDED BY THE REPORTING PHYSICIAN. PLEASE SEE (B)(4) FOR OTHER CASES FROM THE SAME REPORTER.

    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 Required Intervention