BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

    MDR report key: 4122535 · Received September 22, 2014

    Report

    Report Number
    3004608878-2014-00165
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 18, 2014
    Report Date
    September 4, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    HAD INCIDENT WITH GRAFT. NOT CALIBRATING CORRECTLY. ON (B)(6) 2014, ADDITIONAL INFORMATION WAS RECEIVED FROM THE STERILE PROCESSING MANAGER WHO SAID THE INCIDENT WAS REPORTED BY THE SURGEON AS GRAFT WAS NOT CUT EVENLY AND DUE TO THIS ISSUE WHEN THE GRAFT WAS PUT INTO THE MESHER, THE GRAFT SPLIT. THE SURGEON SAID THE ISSUE WAS THE DERMATOME NOT TAKING EVEN GRAFTS. TWO GRAFTS WERE PLANNED AND WERE TAKEN BECAUSE OF THE LARGE AREA NEEDING GRAFTING. NO ADDITION GRAFT WAS NEEDED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587612 PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME SKIN GRAFT PRODUCTS FZW INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1