BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMATOME BLADES (BOX OF 10)

    MDR report key: 1513478 · Received August 27, 2009

    Report

    Report Number
    3004608878-2009-00048
    Event Type
    Injury
    Date Received
    August 27, 2009
    Date of Event
    June 18, 2009
    Report Date
    August 27, 2009
    Manufacturer
    INTEGRA-OHIO
    Product Code
    GFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER MEDWATCH RECEIVED FROM THE FDA STATES THAT "A PADGETT BRAND BLADE WAS INSERTED IN THE ZIMMER BRAND DERMATOME, AND WHEN SKIN WAS HARVESTED, THE BLADE INFLICTED A LACERATION OF 4 INCHES ON EITHER SIDE OF THE GRAFT HARVEST LOCATION ON THE PT'S THIGH WHICH HAD TO BE SUTURED. HARVEST OF GRAFT FROM THE ANTERIOR THIGH FOR GRAFT TO INNER THIGH." A TELEPHONE DISCUSSION WITH, AND SUBSEQUENT E-MAIL FROM THE HOSPITAL'S CORPORATE LOSS PREVENTION MANAGER CONFIRMED THAT "THE SCENARIO TOOK PLACE DURING CHANGE OF SHIFT IN THE OR. THE TECH SETTING UP THE TABLES WAS RELIEVED BY NEXT SHIFT, BUT TABLE SETUP WAS COMPLETE AT THAT POINT. WHEN THE PHYSICIAN ASKED FOR THE BLADE, FOR SOME REASON, THE FRESH SHIFT TECH WENT TO SUPPLIES FOR A BLADE VS LOOKING AT THE SETUP WHERE THE CORRECT BLADE HAD ALREADY BEEN PLACED. RE-EDUCATION OF ALL OR STAFF WAS CONDUCTED ON THE IMPORTANCE OF THE CORRECT BLADE FOR THE CORRECT DERMATOME. PHYSICIANS ALSO RECEIVED RE-EDUCATION ON READING THE BLADE'S BRAND NAME BEFORE THEY INSERT INTO THE DERMATOME THEY ARE USING. THIS CASE WAS A WAKE UP CALL FOR ALL AND BROUGHT HOME THE IMPORTANCE OF READING LABELS CAREFULLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMATOME BLADES (BOX OF 10) SKIN GRAFT PRODUCTS GFD INTEGRA-OHIO

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR