BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 1023764 · Received March 24, 2008

    Report

    Report Number
    1220423-2008-00021
    Event Type
    Other
    Date Received
    March 24, 2008
    Report Date
    March 17, 2008
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    POST-HYSTERECTOMY ABSCESS [SLURRY] [POSTOPERATIVE ABSCESS]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 03/17/2008 FROM A PHYSICIAN REGARDING A FEMALE PATIENT OF UNKNOWN AGE, INITIALS, WHO DEVELOPED A PELVIC ABSCESS AFTER THE APPLICATION OF SEPRAFILM (SLURRY). THE PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY ON AN UNKNOWN DATE, AND SEPRASLURRY WAS USED DURING THE PROCEDURE. AT AN UNSPECIFIED TIME AFTER THE PROCEDURE, THE PT DEVELOPED A PELVIC ABSCESS (QUITE MESSY). AT THE TIME OF THIS REPORT, THE OUTCOME WAS UNKNOWN.

    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 Other| R