BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2222887 · Received August 10, 2011

    Report

    Report Number
    1220423-2011-00033
    Event Type
    Other
    Date Received
    August 10, 2011
    Report Date
    August 4, 2011
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    ANASTOMOTIC LEAK (SLURRY) [ANASTOMOTIC LEAK]. CASE DESCRIPTION: LITERATURE-TRIAL REPORT WAS RECEIVED ON (B)(4) 2011, FROM A PHYSICIAN REGARDING A PT (IDENTIFIERS NOT PROVIDED). THIS REPORT IS FROM A LITERATURE ARTICLE ENTITLED "SEPRAFILM SLURRY DOES NOT INCREASE COMPLICATION RATES AFTER LAPAROSCOPIC COLECTOMY". THERE WERE TWO GROUPS. GROUP 2 CONSISTED OF 50 PTS WHO UNDERWENT LAPAROSCOPIC COLECTOMY FOLLOWED BY THE APPLICATION OF THE SEPRAFILM SLURRY. THE SLURRY WAS CREATED AT THE END OF THE OPERATION BY DISSOLVING TWO PROCEDURE PACKS (EACH CONTAINING SIX 3X6 INCH SHEETS) OF SEPRAFILM IN 120 ML OF WARM NORMAL SALINE. THE SLURRY WAS DELIVERED INTO THE PERITONEAL CAVITY USING A 16-FR. ROBINSON CATHETER. A (B)(6) MALE, UNDERWENT SPLENIC FLEXURE AND INTRACORPOREAL ANASTOMOSIS FOR SPLENIC FLEXURE CANCER AND EXPERIENCED TACHYCARDIA FIVE DAYS AFTER SURGERY, NECESSITATING DIAGNOSTIC LAPAROSCOPY, WHICH SHOWED SOME PURULENT FLUID ADJACENT TO THE STAPLE LINE WHICH WAS DIAGNOSED AS AN ANASTOMOTIC LEAK. THIS WAS MANAGED BY ABDOMINAL WASHOUT AND LAPAROSCOPIC LOOP ILEOSTOMY. THE ACTION TAKEN WITH SEPRAFILM WAS NOT PROVIDED. THE PT'S OUTCOME WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENT OF ANASTOMOTIC LEAK WAS NOT PROVIDED BY THE REPORTING PHYSICIAN.

    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 62 YR Required Intervention