BEUDAMED
    FDA Adverse Event Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLELLULOSE) MEMBRANE

    MDR report key: 1942518 · Received November 29, 2010

    Report

    Report Number
    1220423-2010-00031
    Date Received
    November 29, 2010
    Report Date
    November 17, 2010
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    PMA P950034
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WOUND DEHISCENCE [SLURRY] [WOUND DEHISCENCE]. CASE DESCRIPTION: SPONTANEOUS REPORTED RECEIVED ON (B)(6) 2010 FROM A HEALTH CARE PROVIDER, VIA A COMPANY REP, REGARDING A FEMALE PT (UNK AGE AND INITIAL). THE PT HAD AN UNK MEDICAL HISTORY. THE HCP REPORTED THE PT EXPERIENCED WOUND DEHISCENCE AFTER SEPRAFILM WAS USED AS A SLURRY IN A LAPAROSCOPIC PROCEDURE. THE HCP DID NOT SPECIFY THE NATURE OF THE PROCEDURE. THE HCP THOUGHT THAT THE USE OF SEPRAFILM IN THE LAPAROSCOPIC PROCEDURE CONTRIBUTED TO THE WOUND DEHISCENCE. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK. (B)(4). THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other