BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2230410 · Received August 15, 2011

    Report

    Report Number
    1220423-2011-00037
    Event Type
    Injury
    Date Received
    August 15, 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.

    Description of Event or Problem · 1

    ACUTE CORONARY OCCLUSION (SLURRY) [CORONARY ARTERY OCCLUSION]. FEELING UNWELL WITH ILEUS [SLURRY] [ILEUS]. CASE DESCRIPTION: LITERATURE-TRIAL REPORT WAS RECEIVED ON (B)(6) 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 3 X 6 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) PT WITH A HISTORY OF CORONARY ARTERY DISEASE (CAD), DIABETES, CURRENT SMOKER, STROKE AND MYOCARDIAL INFARCTION (STATUS POSTCORONARY ARTERY BYPASS GRAFT) UNDERWENT LAPAROSCOPIC RIGHT HEMICOLECTOMY FOR A LARGE CECAL POLYP. HE WAS READMITTED TO THE HOSPITAL FEELING UNWELL WITH ILEUS AND DIED THREE DAYS AFTER READMISSION. POSTMORTEM EXAMINATION CONFIRMED ACUTE CORONARY OCCLUSION WITH NO ABNORMALITY IN THE PERITONEAL CAVITY. THE AUTHOR INDICATED THAT THE DEATH WAS NOT RELATED TO ANY INTRAABDOMINAL COMPLICATIONS. THE ACTION TAKEN WITH SEPRAFILM WAS NOT PROVIDED. THE PT'S OUTCOME WAS FATAL. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENTS OF CORONARY ARTERY DISEASE AND ILEUS 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 58 YR Death| H