BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT

    MDR report key: 2800922 · Received October 18, 2012

    Report

    Report Number
    3004608878-2012-00186
    Event Type
    Injury
    Date Received
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    INTEGRA LIFESCEIENCES CORP OH/USA
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    THE REPORTER NOTED THE DERMATOME WAS "OUT OF CALIBRATION AND ADVISED IT TORE TISSUE". ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED BY INTEGRA NUMEROUS TIMES BUT WAS NOT PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT SKIN GRAFT PRODUCTS GFD INTEGRA LIFESCEIENCES CORP OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1