BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL B 110V ELECTRO DERMATOME COMPLETE KIT

    MDR report key: 3001955 · Received March 11, 2013

    Report

    Report Number
    3004608878-2013-00042
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: "NOT GRAFTING SKIN RIGHT-CUTTING IS UNEVEN; NO PATIENT INJURY". ADDITIONAL INFORMATION WAS REQUESTED. ON (B)(6) 2013, THE REPORTER NOTED THERE WAS NO PATIENT INJURY OR DELAY IN SURGERY; A SPARE DEVICE WAS AVAILABLE WHICH FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101390 MODEL B 110V ELECTRO DERMATOME COMPLETE KIT SKIN GRAFT PRODUCTS GFD INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1