BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 4093211 · Received August 21, 2014

    Report

    Report Number
    1526350-2014-00416
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 23, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO ZIMMER THAT THE AIR DERMATOME HANDPIECE MOVED TOO SLOWLY AND CHEWED UP THE SKIN. IT WAS INDICATED THAT THERE WAS NO HARM OR SURGICAL DELAY INVOLVED. THERE WAS NO ADDITIONAL CLINICAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504648 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1