BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2582773 · Received May 18, 2012

    Report

    Report Number
    1220423-2012-00016
    Event Type
    Other
    Date Received
    May 18, 2012
    Date of Event
    January 1, 2012
    Report Date
    May 11, 2012
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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

    INFECTION AFTER CESAREAN [POST PROCEDURAL INFECTION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A PHYSICIAN REGARDING A FEMALE PT, INITIALS UNK. THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR CESAREAN SECTION. ON AN UNSPECIFIED DATE IN (B)(6)2012, THE PT INITIATED SEPRAFILM MEMBRANE, ONE SHEET. ON AN UNSPECIFIED DATE IN (B)(6) 2012, THE PT EXPERIENCED INFECTION AFTER CESAREAN. TREATMENT RECEIVED, IF ANY, WAS NOT PROVIDED. THE OUTCOME OF THE EVENT OF INFECTION AFTER CESAREAN WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF INFECTION AFTER CESAREAN WAS ASSESSED AS MILD. THE REPORTER ASSESSED THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENT OF INFECTION AFTER CESAREAN AS UNASSESSABLE. THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    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