BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME II HANDPIECE

    MDR report key: 3874623 · Received April 24, 2014

    Report

    Report Number
    1526350-2014-00319
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 9, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURER ON 08/08/2013 AND WAS PREVIOUSLY RETURNED FOR REPAIR ON 12/20/2013 FOR THE SAME ISSUE. THE DEVICE WAS NOT RETURNED TO ZIMMER SURGICAL FOR EVALUATION AND REPAIR; THEREFORE, THE CUSTOMER'S REPORTED EVENT COULD NOT BE CONFIRMED. THE CAUSE OF THE REPORTED ISSUE IS UNDETERMINED. INVESTIGATION OF THE BUBBLING AND PEELING OF THE SURFACE COATING OBSERVED WITH AIR DERMATOME II DEVICES AND REPLACED COMPONENTS, IS STILL ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COATING ON THE WIDTH PLATES AND HANDPIECE OF THE ZIMMER AIR DERMATOME II HANDPIECE WAS BUBBLING OUT. NO ADD'L CLINICAL INFO WAS REC'D PRIOR TO TIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248160 ZIMMER AIR DERMATOME II HANDPIECE ZIMMER AIR DERMATOME II HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1