BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

    MDR report key: 1063697 · Received June 20, 2008

    Report

    Report Number
    3003418325-2008-00016
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 20, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED 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 REPORTED THAT "IN THE MIDDLE OF CUTTING A SKINGRAFT, THE UNIT STOPPED, HAVING NO POWER". THE USER SWITCHED TO A MODEL B DERMATOME TO FINISH TAKING THE GRAFT. THE PROCEDURE WAS DELAYED AND THE PT WAS UPSET." ON 06/19/2008 ADDITIONAL INFORMATION: A SURGICAL NURSE REPORTED THAT A SECOND GRAFT WAS TAKEN WHEN USING THE MODEL B DERMATOME; IT WAS NOT USED TO FINISH THE FIRST GRAFT AS EARLIER REPORTED.

    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