BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2330071 · Received November 3, 2011

    Report

    Report Number
    1220423-2011-00045
    Event Type
    Death
    Date Received
    November 3, 2011
    Report Date
    October 24, 2011
    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

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

    Description of Event or Problem · 1

    AFFERENT LOOP SYNDROME [AFFERENT LOOP SYNDROME]. STRANGULATION ILEUS [MECHANICAL ILEUS]. ABDOMINAL PAIN [ABDOMINAL PAIN]. SEPTIC SHOCK [SEPTIC SHOCK]. CASE DESCRIPTION: LITERATURE-SPONT REPORT RECEIVED ON (B)(6) 2011 FROM AN HCP REGARDING AN APPROX (B)(6)-OLD MALE PT, INITIALS UNK, WHO EXPERIENCED ABDOMINAL PAIN, SEPTIC SHOCK, STRANGULATION ILEUS AND AFFERENT LOOP SYNDROME. THE TITTLE OF THE LITERATURE ARTICLE FROM WHICH THIS REPORT WAS OBTAINED WAS NOT PROVIDED. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. THE PT EXPERIENCED ABDOMINAL PAIN, FOR WHICH HE WAS HOSPITALIZED. THE PT EXPERIENCED SEPTIC SHOCK, STRANGULATION ILEUS AND AFFERENT LOOP SYNDROME. THE OUTCOME OF THE PT WAS REPORTED AS DEATH (DATE NOT PROVIDED). THE CAUSE OF DEATH WAS NOT PROVIDED. FURTHER INFO IS EXPECTED. THE PRODUCT LOT NUMBER WAS NOT REPORTED.

    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 UNK Death| H