BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 3283855 · Received August 7, 2013

    Report

    Report Number
    1220423-2013-00017
    Event Type
    Injury
    Date Received
    August 7, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 29, 2013
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLERGIC REACTION [HYPERSENSITIVITY]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A SURGEON REGARDING A (B)(6) MALE PT, INITIALS (B)(6). THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR ESOPHAGEAL CANCER, ESOPHAGEAL CANCER SURGERY, GASTRIC TUBE CANCER AND PREOPERATIVE CONDITION OF PNEUMONIA. ON UNSPECIFIED DATE IN (B)(6) 2013, THE PT UNDERWENT RESECTION OF GASTRIC TUBE AND ENTEROSTOMY OF SMALL INTESTINE WITH CONCOMITANT USE OF TUBE (NCJ KIT) AND ONE SHEET OF SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) WAS PLACED UNDER THE INCISION SITE TO REDUCE THE EXTENT AND SEVERITY OF POSTOPERATIVE ADHESION FOLLOWING ADHESIOTOMY FOR ADHESIVE ILEUS. THE LOT NUMBER FOR SEPRAFILM WAS NOT PROVIDED. ON (B)(6) 2013, THE PT DEVELOPED ALLERGIC REACTION AT THE INCISION SITE. THE EVENT OF ALLERGIC REACTION WAS ASSESSED SERIOUS DUE TO HOSPITALIZATION. AS OF (B)(6) 2013, THE PT HAD NOT YET RECOVERED FROM THE EVENT. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF ALLERGIC REACTION WAS MODERATE. THE REPORTING SURGEON ASSESSED THE RELATIONSHIP OF SEPRAFILM WITH THE EVENT AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371761 SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE BIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY (SEPRAFILM/PACK) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization