BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT

    MDR report key: 2657653 · Received July 10, 2012

    Report

    Report Number
    3004608878-2012-00131
    Event Type
    Injury
    Date Received
    July 10, 2012
    Date of Event
    May 1, 2012
    Report Date
    July 10, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT WAS EVALUATED AND AN INVESTIGATION HAS BEEN COMPLETED. THE INITIAL COMPLAINT RECEIVED BY INTEGRA WAS VERIFIED WHICH NOTED "DERMATOME WAS CHOPPING." ON INVESTIGATION, NICKS AND SCRATCHES WERE OBSERVED ON THE OSCILLATING PIN AND THE LEADING EDGE OF THE WIDTH CLIPS WERE WORN ON THE RETURNED DEVICE. THIS MAY HAVE CAUSED ISSUES WITH THE GRAFT QUALITY OR OPERATION OF THE BLADE. THE RETURNED DEVICE EXCEEDED THE PREVENTATIVE MAINTENANCE SCHEDULE. THIS DEVICE WAS MFG IN 1993 AND IT WAS LAST IN FOR SVC IN 2002. BASED ON THE REPORTED INFO AND THE INVESTIGATION RESULTS PROVIDED, INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    "MODEL B DERMATOME WAS CHOPPING. PT CONTACT UNK." INTEGRA COMPLAINTS DEPT MADE SEVERAL ATTEMPTS TO OBTAIN ADD'L INFO. ON (B)(6) 2012, MEDWATCH FROM (B)(6) HOSP UF/IMPORTER REPORT (B)(4) WAS RECEIVED BY INTEGRA LIFE SCIENCES, (B)(4). "THERE WAS A PROCEDURE OF SPLIT THICKNESS GRAFT TO OPEN A WOUND IN THE PERIVAGINAL/PERIRECTAL AREA. ON THE FIRST ATTEMPT THE BLADE SKIPPED ACROSS THIGH CAUSING UNEVEN USABLE GRAFT. THE SECOND ATTEMPT WAS WITH A NEW BLADE. IT SKIPPED AS WELL CAUSING ANOTHER UNUSABLE GRAFT. A NEW ELECTRIC DERMATOME WAS USED. THE THIRD ATTEMPT WAS SUCCESSFUL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT SKIN GRAFT PRODUCTS GFD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR