BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL B 230V ELECTRO DERMATOME COMPLETE KIT

    MDR report key: 3880886 · Received April 9, 2014

    Report

    Report Number
    3004608878-2014-00039
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Report Date
    March 24, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE SUDDENLY STOPPED DURING SURGERY ANAD REPORTED EXCESSIVE HEAT WAS PRODUCED BY THE DEVICE. ADDITIONAL CLINICAL INFO WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213393 MODEL B 230V ELECTRO DERMATOME COMPLETE KIT NONE GFD INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1