BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADGETT AIR DERMATOME, MODEL C

    MDR report key: 1041343 · Received May 8, 2008

    Report

    Report Number
    3003418325-2008-00009
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 17, 2008
    Report Date
    May 6, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED, AND AN INVESTIGATION HAS BEEN INITIATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE DEVICE SHREDDED A SKIN GRAFT, AND THAT A SECOND GRAFT HAD TO BE TAKEN. ON 4/24/08 ADD'L INFO: BIOMEDICAL ENGINEER AT THE FACILITY REVEALED THAT THE DELIVERY OF THE NITROGEN PRESSURE TO THE DEVICE, FROM THE SOURCE IN THE VARIOUS OPERATING ROOMS AT THE FACILITY, MAY VARY AND AFFECT THE SPEED OF THE DERMATOME. ON 5/1/08 ADD'L INFO: A NURSE AT THE USER FACILITY REPORTED VIA TELEPHONE CONVERSATION, ON THIS DAY, THAT HER INQUIRY OF THE OPERATING ROOM STAFF, PRESENT AT THE TIME OF INCIDENT, REVEALED THAT THEY THOUGHT THAT THE DEVICE OPERATED PROPERLY. THEY REVEALED THAT THE DEVICE WAS SET "TOO THIN" WHEN TAKING THE FIRST GRAFT, AND SO IT SHREDDED THE TISSUE. THE DEVICE WAS "NOT RESET" FOR A DIFFERENT THICKNESS FOR THE SECOND GRAFT, AND WHEN THE SURGEON SAW IT START TO SHRED, AGAIN HE STOPPED. PRIOR TO TAKING THE THIRD GRAFT, THE "DEVICE WAS SET TO TAKE A THICKER SPECIMEN" AND THE GRAFT WAS TAKEN SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PADGETT AIR DERMATOME, MODEL C PADGETT AIR DERMATOME GFD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1