BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME II HANDPIECE

    MDR report key: 4110189 · Received September 11, 2014

    Report

    Report Number
    1526350-2014-00426
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 INITIALLY REPORTED THAT THE ZIMMER AIR DERMATOME II HANDPIECE HAD PAINT UNDER THAT BLADE THAT WAS BUBBLING AND PEELING OFF. THE EVENT WAS DISCOVERED DURING KIT INSPECTION AND THERE WAS NO PATIENT INVOLVEMENT OR HARM ASSOCIATED WITH THE REPORT. AN ALTERNATE DEVICE WAS RETRIEVED TO COMPLETE THE SURGERY WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563267 ZIMMER AIR DERMATOME II HANDPIECE ZIMMER AIR DERMATOME II HANDPIECE GFD ZIMMER SURGICAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1