BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 1053029 · Received May 27, 2008

    Report

    Report Number
    1220423-2008-00026
    Event Type
    Other
    Date Received
    May 27, 2008
    Report Date
    May 19, 2008
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOCALIZED INFECTION [LOCALISED INFECTION]. LEFT HEPATIC ARTERY STENOSIS [HEPATIC ARTERY STENOSIS]. LEFT HEPATIC NECROSIS [HEPATIC NECROSIS]. SEPSIS [SEPSIS]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 19-MAY-2008 FROM A PHYSICIAN VIA SALES REP REGARDING A (B) (6) FEMALE (INITIALS NOT PROVIDED). ON UNK DATE DURING A SURGICAL PROCEDURE FOR BILIARY ATRESIA THE PT RECEIVED SEPRAFILM. REPORTEDLY, POSTOPERATIVE FOLLOW-UP WAS REMARKABLE FOR LEFT HEPATIC ARTERY STENOSIS AND LEFT HEPATIC NECROSIS LEADING TO RE-OPERATION. DURING SECOND LOOK SURGERY, AN INFECTION IN THE AREA OF PLACEMENT OF SEPRAFILM WAS NOTED. ACCORDING TO THE PHYSICIAN THE SEPSIS WAS DOUBTFULLY RELATED TO SEPRAFILM, BUT PROBABLY CAUSED BY THE ISCHEMIC COMPLICATION. AS OF THE DATE OF RECEIPT OF THIS REPORT THE PT HAD NOT RECOVERED.

    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 02 MO Required Intervention