BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 1675788 · Received May 5, 2010

    Report

    Report Number
    1220423-2010-00010
    Event Type
    Other
    Date Received
    May 5, 2010
    Report Date
    April 28, 2010
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STERILE ABSCESS [ABSCESS STERILE]. ADHESION FOLLOWING SEPRAFILM PLACEMENT [PRODUCT ADHESION ISSUE]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A PHYSICIAN (SURGEON) VIA A COMPANY REP REGARDING 1-2 FEMALE PTS OF UNK AGE, INITIALS AND RELEVANT MEDICAL HISTORY. THE PT(S) UNDERWENT AN UNK SURGERY ON AN UNK DATE IN WHICH SEPRAFILM WAS PLACED. POST-OPERATIVELY, THE PTS PRESENTED WITH STERILE ABSCESS. ONE OF THE PTS SPECIFICALLY NEEDED TO BE RE-OPERATED ON TWICE FOR POST-OPERATIVE PAIN. DURING THE RE-OPERATIONS, EXTREME LYSIS WAS NEEDED FOR ADHESIONS EXPERIENCED FOLLOWING SEPRAFILM PLACEMENT. NO FURTHER INFO WAS PROVIDED. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS UNK. (B)(4). MFR'S COMMENT: 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, CARBOXYMETHYLCELLULOSE) MEMBRANE BIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY (SEPRAFILM/PACK) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention