BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT

    MDR report key: 1812796 · Received July 21, 2010

    Report

    Report Number
    3004608878-2010-00065
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORP. (INTEGRA-OHIO)
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    INTEGRA RECEIVED A LETTER FROM (B)(6) REGARDING REPORT (B)(4) THAT WAS RECEIVED BY THE FDA THROUGH THE MEDWATCH PROGRAM. THE VOLUNTARY MEDWATCH WAS DATED 01-JULY-2010. THE REPORT STATED THAT THE PT WAS HAVING SURGERY FOR A LEFT LOWER EXTREMITY SPLIT THICKNESS SKIN GRAFT FOR 6 YR HISTORY OF LOWER LIMB EXTREMITY WOUND. THE PADGETT DERMATOME WAS BROUGHT ONTO THE FIELD, AND SET TO 5/1000 INCH. THE THICKNESS WAS CONFIRMED WITH SCALPEL BLADE. THE SKIN WAS PREVIOUSLY HELD ON TENSION AND UTILIZING A 2-INCH GUARD, THE SKIN GRAFT WAS TAKEN FROM THE LEFT LATERAL THIGH BENEATH THE PT'S PREVIOUS SKIN GRAFT DONOR SITE. AFTER A SHORT SEGMENT (APPROX THREE INCHES IN LENGTH) WAS TAKEN, IT WAS NOTICED THAT THE GRAFT WAS MUCH THICKER THAN THE 5/1000 SETTING ON THE DERMATOME, AND THE HARVESTING OF THE SKIN WAS ABORTED. EXAMINATION OF THE DONOR SITE REVEALED A NEAR FULL THICKNESS DONOR SITE. THE SKIN GRAFT WAS REPLACED ON THE DONOR SITE. THE DERMATOME WAS DISASSEMBLED TO SEE IF SOMETHING HAD BEEN LODGED WITH THE BLADE, PUSHING IT DOWN. HOWEVER, NOTHING WAS IDENTIFIED AND THE BLADE APPEARED TO BE WELL SEATED. THE EVENT REQUIRED THE PT TO RETURN TO SURGERY, THE FOLLOWING DAY FOR ANOTHER PROCEDURE. THE MEDWATCH REPORTED: DATES OF USE: 20 YEARS (B) (6) 1990-2010. INTEGRA REQUESTED ADDITIONAL CLINICAL AND CONTACT INFO FROM THE (B)(6). INTEGRA HAS RECEIVED NO OTHER COMPLAINT OF THIS TYPE WITH THE SAME EVENT DATE.

    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 CORP. (INTEGRA-OHIO)

    Patients

    Seq Age Sex Outcome Treatment
    1