BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME II HANDPIECE

    MDR report key: 3831854 · Received March 6, 2014

    Report

    Report Number
    1526350-2014-00170
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 7, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME II HANDPIECE HAD A PROBLEM WITH THE COATING. IT HAD STARTING TO CRACK. THE ISSUE WAS NOTICED DURING CLEANING OF THE DEVICE THERE WAS NO SURGICAL INVOLVEMENT ASSOCIATED WITH THE REPORTING OF THE DEVICE AND THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135813 ZIMMER AIR DERMATOME II HANDPIECE ZIMMER AIR DERMATOME II HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1