BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2214115 · Received July 18, 2011

    Report

    Report Number
    1220423-2011-00021
    Event Type
    Other
    Date Received
    July 18, 2011
    Report Date
    July 6, 2011
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SEVERE POST-PROCEDURAL INFECTION [POST PROCEDURAL INFECTION]. SURGICAL INCISION OPENED [WOUND DEHISCENCE] BECAME SEPTIC [SEPSIS]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2010, FROM A PHYSICIAN VIA A COMPANY REP REGARDING A (B)(6) FEMALE PT, INITIALS UNK. THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR PREGNANCY. ON AN UNSPECIFIED DATE, THE PT UNDERWENT A CESAREAN OPERATION FOR DELIVERY OF BABY. THE HCP REPORTED THAT SEPRAFILM WAS PLACED AT THE UTERINE INCISION (UNK IF PLACED AT OTHER SITES) AND THEN THE INCISION WAS CLOSED. AFTERWARDS, THE PT EXPERIENCED SEVERE INFECTION AND BECAME SEPTIC (ONSET UNK). THE INCISION OPENED AND THE HCP HAD TO GO BACK IN AND PERFORM ABDOMINAL HYSTERECTOMY. THE HCP ASSESSED THE EVENTS TO BE "POSSIBLY" RELATED TO SEPRAFILM USE IN THE PT. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE AVAILABLE. 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 21 YR Required Intervention