BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLECELLULOSE) MEMBRANE

    MDR report key: 2992732 · Received March 4, 2013

    Report

    Report Number
    1220423-2013-00007
    Event Type
    Other
    Date Received
    March 4, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 22, 2013
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE SEPRAFILM IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    PELVIC LIQUID COLLECTION WITH PUS [PELVIC ABSCESS]. INCREASED ABDOMINAL FLUID WITH PUS [ABDOMINAL ABSCESS]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A PHYSICIAN REGARDING A FEMALE PATIENT, (B)(6). THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PATIENT UNDERWENT POSTERIOR PELVIC EXENTERATION PERFORMED WITH RETROPERITONEAL LYMPHADENECTOMY, OMENTECTOMIA, PERITONIECTOMIA OF BOTH RIGHT AND LEFT COSTOPHRENIC RECESSES. COLORECTAL ANASTOMOSIS WAS DONE WITH CIRCULAR STAPLER AND DUE TO EXTENT OF SURGERY, 03 SHEETS OF SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE, WERE PLACED ON PELVIS UNDER THE BOWEL PRIOR TO ABDOMINAL WALL CLOSURE. ON AN UNSPECIFIED DATE, THE PATIENT DISCHARGED HOME. ON (B)(6) 2013, 15 DAYS LATER, THE PATIENT RETURNED TO THE HOSPITAL WITH INCREASED ABDOMINAL FLUID AND WAS DIAGNOSED WITH PELVIC LIQUID COLLECTION VIA TOMOGRAPHY. THE PATIENT'S PARACENTESIS AND LIQUID ANALYSIS WERE PERFORMED WHICH REVEALED NO BACTERIAL GROWTH AND LYMPHATIC OR URINARY FISTULA WAS DISCARDED. IT WAS REPORTED THAT, 15 DAYS AFTER PARACENTESIS, THE PATIENT CAME WITH NEW COMPLAINTS OF INCREASED ABDOMINAL VOLUME WITH PUS WHICH SHOWED NEW COLLECTION OF FLUID AND WAS DRAINED BY PARACENTESIS. THE PATIENT HAD NOT YET RECOVERED FROM THE EVENTS OF INCREASED ABDOMINAL FLUID WITH PUS AND PELVIC LIQUID COLLECTION AND REQUIRED PUNCTURES. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF INCREASED ABDOMINAL FLUID WITH PUS AND PELVIC LIQUID COLLECTION WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE A CAUSAL RELATIONSHIPS BETWEEN SEPRAFILM AND BOTH THE EVENTS. ADDITIONALLY, THE PHYSICIAN REPORTED THAT THE USE OF SEPRAFILM WAS AN UNPLEASANT EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91557 SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLECELLULOSE) MEMBRANE BIIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY (SEPRAFILM/PACK) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention