BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 739791 · Received July 21, 2006

    Report

    Report Number
    3002719998-2006-00006
    Event Type
    Other
    Date Received
    July 21, 2006
    Date of Event
    May 11, 2006
    Report Date
    July 20, 2006
    Manufacturer
    *
    Product Code
    HWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: INVESTIGATION/REVIEW OF INTERNAL RECORDS: DONOR, SEROLOGICAL RESULTS, MEDICAL RELEASE, MANUFACTURING, QUALITY ASURANCE/QUALITY CONTROL REVIEWS, AND PROCESSING CULTURES. RESULT: MANUFACTURING RECORD/HISTORY REVIEW INDICATES GRAFT PASSED ALL QA, AND MANUFACTURING CONTROLS. PREPROCESSING CULTURES SHOWED NO GROWTH. STERILITY (14-DAY) AND DESTRUCTIVE OVAL/TISSUE CULTURES NEGATIVE FOR AEROBIC, AND ANAEROBIC GROWTH. DONOR SEROLOGY TESTS NEGATIVE. CONCLUSIONS: BIOCLEANSE, THE PROCESSING METHOD UTILIZES FOR IMPLANTED GRAFT, IS A VALIDATED PROCESS FOR STERILIZING ALLOGRAFT TISSUE. THE ONSET OF INFECTION WEEKS AFTER INITIAL PROCEDURE IS MOST LIKELY ASSOCIATED WITH CONCURRENT IMPLANTATION OF HARDWARE. INFECTION FROM A SOURCE OTHER THAN ALLOGRAFT TISSUE IS LIKELY.

    Description of Event or Problem · 1

    PATIENT DEVELOPED POSTOPERATIVE INFECTION 2+ WEEKS AFTER SURGICAL ALLOGRAFT IMPLANTATION PROCEDURE. PATIENT HAD IRRIGATION, AND DRAINAGE (I & D) AND PLACED ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * HWF * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other