BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

    MDR report key: 1052725 · Received May 23, 2008

    Report

    Report Number
    3003418325-2008-00012
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 23, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTER INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS THAT THE ON/OFF SWITCH IS DIFFICULT TO MOVE, AND THAT THE DEVICE DOES NOT CALIBRATE PROPERLY, IT IS CUTTING TOO DEEP. THE USER FURTHER REPORTS THAT THERE WAS PATIENT CONTACT WITH THE DEVICE, AND THERE WAS NO PATIENT INJURY. ON 5/22/2008 ADDITIONAL INFORMATION: THE NURSE, SPECIALTY TEAM LEADER REPORTS THAT THE FIRST GRAFT WAS TAKEN WAS "A LITTLE DEEPER IN THE MIDDLE" OF THE GRAFT, AND REQUIRED A FEW SMALL STITCHES TO LIFT THAT AREA OF THE HARVEST SITE. SHE CONFIRMED THAT IS WAS NOT CONSIDERED A PATIENT INJURY. A SECOND GRAFT WAS TAKEN WITH A DIFFERENT DERMATOME AND WAS PERFECT. THE SECOND GRAFT WAS TAKEN BECAUSE THE FIRST GRAFT WAS UNSATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME PADGETT ELECTRIC DERMATOME GFD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1