BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURAGEN PLUS 4X5

    MDR report key: 966684 · Received December 19, 2007

    Report

    Report Number
    1121308-2007-00019
    Event Type
    Death
    Date Received
    December 19, 2007
    Date of Event
    July 26, 2007
    Report Date
    December 18, 2007
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE NATURE OF THE PRODUCT TO ABSORB INTO THE BODY, THE DURAGEN PLUS UNIT IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY BY VOICE MAIL AND LETTER. TO DATE NO RESPONSE HAS BEEN RECEIVED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR ANY ABNORMALITIES. THE DHR INDICATED THAT ONE UNIT OF DURAGEN PLUS FOUND WITH A FOREIGN MATTER AND REJECTED. THE LOT WAS 100% INSPECTED FOR PARTICULATES FINDING NO ADDITIONAL UNITS. THE SEAL INTEGRITY TESTS BOTH PRIOR TO AND POST STERILIZATION MET SPECIFICATIONS. NO MANUFACTURING ISSUES WERE REPORTED. THE VALIDATED STERILIZATION CYCLE WAS REVIEWED. THE STERILIZATION LOAD METAL CYCLE PARAMETERS. BIOLOGICAL INDICATORS WERE NEGATIVE FOR GROWTH. PYROGEN TESTING MET SPECIFICATIONS. AS PART OF THE CONTINUING INVESTIGATION INTO THIS COMPLAINT A LITERATURE SEARCH WILL BE CARRIED OUT SEARCHING FOR FUNGAL INFECTIONS ASSOCIATED WITH CRANIAL PROCEDURES AND/OR COLLAGEN BASED MATERIALS. A SECOND ATTEMPT BY LETTER WILL BE MADE TO OBTAIN ADDITIONAL INFORMATION, SUCH AS THE RESULTS OF THE LABORATORY WORK CONCOMITANT MEDICATIONS, DEVICES AND THERAPIES AND PATIENT MEDICAL HISTORY, FROM THE USER FACILITY. A REVIEW OF THE COMPLAINT DATABASE WILL BE CONDUCTED TO SURVEY ALL ALLEGATIONS OF INFECTIONS ASSOCIATED WITH THE DURAGEN FAMILY OF PRODUCTS.

    Description of Event or Problem · 1

    THE USER FACILITY INFORMED THE INTEGRA LIFESCIENCES CORPORATION'S ("INTEGRA") SALES REPRESENTATIVE THAT, A FEMALE PATIENT DEVELOPED AN INFECTION AFTER THE SURGERY. THE LABORATORY COULD NOT IDENTIFY THE CAUSE OF THE INFECTION, WHEN REPORTED. ON DECEMBER 3, 2007, INTEGRA PRODUCT SUPPORT SPOKE TO A USER FACILITY REPRESENTATIVE. THE SURGERY WAS PERFORMED FIVE MONTHS EARLIER. THE PATIENT DEVELOPED AN INFECTION WEEKS AFTER THE SURGERY. THE PATIENT WAS PLACED ON A REGIMENT OF ANTIBIOTICS. THE PATIENT EVENTUALLY DIED ABOUT 2 MONTHS AGO AND EXACT CAUSE IS UNKNOWN. THE AUTOPSY RESULTS WERE NOT YET AVAILABLE. THE CULTURES COULD NOT BE IDENTIFIED BY THE HOSPITAL LABORATORY, AND WERE SENT TO THE CDC. THE RESULTS OF THE CULTURES ARE NOT YET AVAILABLE, BUT THE USER FACILITY BELIEVES THAT THE ORGANISM IS FUNGAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAGEN PLUS 4X5 DURAGEN PLUS GXQ INTEGRA LIFESCIENCES 1071476

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death