BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADGETT DERMATOME

    MDR report key: 2033264 · Received March 24, 2011

    Report

    Report Number
    MW5019957
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 24, 2011
    Manufacturer
    INTEGRA LIFE SCIENCES
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON TRIED TO USE THE DERMATOME FOR A PARTIAL THICKNESS SKIN GRAFT AND THE INSTRUMENT FAILED, LEAVING A SMALL WOUND WITH JAGGED EDGES. PHYSICIAN HAD TO EXCISE SKIN FROM ANOTHER LOCATION TO COMPLETE THE GRAFT TO THE THUMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PADGETT DERMATOME NONE GFD INTEGRA LIFE SCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other