BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2925245 · Received January 17, 2013

    Report

    Report Number
    1220423-2013-00004
    Event Type
    Other
    Date Received
    January 17, 2013
    Date of Event
    October 1, 2012
    Report Date
    December 18, 2012
    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

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

    Description of Event or Problem · 1

    ADHESIONS BETWEEN LOOPS AND ABDOMINAL WALL (ABDOMINAL ADHESIONS). LACK OF EFFICACY (DEVICE INEFFECTIVE). CASE DESCRIPTION: SPONTANEOUS REPORT WAS REC'D ON (B)(6) 2012 (ADDITIONAL INFO WAS REC'D ON (B)(4) 2003) FROM A PHYSICIAN REGARDING A PT (DEMOGRAPHIC NOT PROVIDED), INITIALS (B)(6). ON AN UNSPECIFIED DATE IN (B)(6) 2012, THE PT UNDERWENT PELVIS EXENTERATION SURGERY AND THREE SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) SHEETS WERE PLACED IN THE CANCER PT WITH TUMOR OF THE RECTUM USING CONVENTIONAL CHEMOTHERAPY (WITHOUT RADIOTHERAPY). THE SITES OF APPLICATION WERE IN THE PELVIS, NEAR THE BLADDER AND BETWEEN THE SMALL INTESTINE AND ABDOMINAL WALL. ON AN UNSPECIFIED DATE (AFTER ONE MONTH FROM THE INITIAL SURGERY), THE PT UNDERWENT REOPERATION AND THE PHYSICIAN OBSERVED AN IMMENSE AMOUNT OF ADHESIONS BETWEEN LOOPS AND THE ABDOMINAL WALL (FREE ADHESIONS) WHICH DID NOT ALLOW HIM TO ENTER THE ABDOMEN. IT WAS REPORTED THAT AFTER THE PHYSICIAN USED THIS SEPRAFILM PACKAGE HIS PT DIDN'T EXPERIENCE THE EXPECTED EFFECTS (LACK OF EFFICACY), BECAUSE ADHERENCE OCCURRED AT THE APPLICATION SITE. THE OUTCOME FOR THE EVENT OF ADHESIONS BETWEEN LOOPS AND THE ABDOMINAL WALL WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF ADHESIONS BETWEEN LOOPS AND THE ABDOMINAL WALL WAS NOT PROVIDED THE REPORTING PHYSICIAN DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN SEPRAFILM AND BOTH EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26780 SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE BIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY (SEPRAFILM/PACK) UNK 11NP716

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CHEMOTHERAPEUTICS NOS