BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL S6 ELECTRIC DERMATOME SET, COMPLETE

    MDR report key: 4180727 · Received October 15, 2014

    Report

    Report Number
    3004608878-2014-00184
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 22, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO 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

    IT WAS REPORTED : THE THICKNESS OF THE GRAFT ON ONE SIDE IS DIFFERENT FROM THE OTHER SIDE. ADDITIONAL INFORMATION WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654685 MODEL S6 ELECTRIC DERMATOME SET, COMPLETE NA GFD INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1