BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 2980135 · Received February 21, 2013

    Report

    Report Number
    1526350-2013-00084
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER DERMATOME WOULD NOT PRODUCE A GRAFT. NO ADD'L CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75233 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1