BEUDAMED
    FDA Adverse Event Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 1101923 · Received August 5, 2008

    Report

    Report Number
    1220423-2008-00034
    Date Received
    August 5, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 23, 2008
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    PMA P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PELVIC ABSCESS [PELVIC ABSCESS]. CASE DESCRIPTION: INITIAL INFORMATION WAS RECEIVED ON 23-JUL-2008 FROM HCP VIA COMPANY REPRESENTATIVE. THE REPORTER INDICATED (4) DIFFERENT FEMALE PATIENTS DEVELOPED PELVIC ABSCESS AFTER PLACEMENT OF SEPRAFILM. THIS REPORT IS FOR THE FIRST OF FOUR PATIENTS. AT 3-4 WEEKS PRIOR TO THE SUBMISSION OF THIS REPORT, THE PATIENT RECEIVED SEPRAFILM PLACEMENT AFTER A CAESARIAN SECTION AND DEVELOPED PELVIC ABSCESS. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PATIENT WAS UNKNOWN. NO FURTHER INFORMATION PROVIDED. (B) (6).

    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 Other