BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 3010334 · Received March 14, 2013

    Report

    Report Number
    1220423-2013-00008
    Event Type
    Injury
    Date Received
    March 14, 2013
    Report Date
    January 10, 2013
    Manufacturer
    GENZYME BIOSUERGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS ONLY LIMITED INFORMATION HAS BEEN OBTAINED SO FAR, IT IS DIFFICULT TO ASSESS A CAUSE AND EFFECT RELATIONSHIP.

    Description of Event or Problem · 1

    POST OP ILEUS [POSTOPERATIVE ILEUS]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A PHYSICIAN REGARDING A PATIENT, INITIALS UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, SEPRAFILM MEMBRANE WAS PLACED IN AN UNSPECIFIED LOCATION (NUMBER OF SHEETS NOT PROVIDED). THE LOT NUMBER FOR SEPRAFILM WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED POST-OPERATED ILEUS. THE EVENT WAS ASSESSED AS SERIOUS DUE TO HOSPITALIZATION. ON AN UNSPECIFIED DATE, THE PATIENT RECOVERED FROM POST-OPERATIVE. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENT. IT WAS REPORTED THAT THE SURGEON COULD NOT DETERMINE THE REASON FOR THE DEVELOPMENT OF POST-OPERATIVE ILEUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108383 SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE BIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSUERGERY (SEPRAFILM/PACK) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization