BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 1870881 · Received October 7, 2010

    Report

    Report Number
    1220423-2010-00023
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    January 1, 2009
    Report Date
    April 21, 2009
    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

    INFECTED FLUID COLLECTED IN THE PELVIS [PELVIC FLUID COLLECTION]. CASE DESCRIPTION: AN SPONTANEOUS REPORT WAS RECEIVED ON 21-APR-2009 FROM AN HCP, VIA A COMPANY REPRESENTATIVE REGARDING A FEMALE, PATIENT, NAME AND AGE NOT KNOWN, WHO EXPERIENCED COLLECTION OF INFECTED FLUID IN THE PELVIS, TWO WEEKS POST-OPERATION. THE HCP REPORTED THAT THE PATIENT UNDERWENT TOTAL LAPAROSCOPIC HYSTERECTOMY AND HAD TO UNDERGO A HOSPITALIZATION TWO WEEKS POST-OP DUE TO INFECTED FLUID COLLECTION IN THE PELVIS. FOR OTHER ADVERSE EVENTS REPORTED IN THE SAME SOURCE DOCUMENT, (B)(4). MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.

    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 Hospitalization