BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3060623 · Received April 5, 2013

    Report

    Report Number
    1526350-2013-00166
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; 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 ELECTRIC DERMATOME WAS NOT WORKING PROPERLY. THE BLADE WAS LOADED INTO THE DEVICE AND THEN THE DEVICE MADE AN UNUSUAL LOUD NOISE AND SIMPLY WOULD NOT WORK. THERE WAS NO PT INVOLVEMENT AND A REPLACEMENT DEVICE WAS RETRIEVED AND USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141713 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1