BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME II HANDPIECE

    MDR report key: 3905226 · Received May 28, 2014

    Report

    Report Number
    1526350-2014-00369
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE BUBBLING AND PEELING OF THE SURFACE COATING OBSERVED WITH AIR DERMATOME II DEVICES AND RELATED COMPONENTS, IS STILL ONGOING. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A F/U 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 MATERIAL ON THE ZIMMER AIR DERMATOME II HANDPIECE BLISTERED ONCE AGAIN SINCE IT HAS BEEN RETURNED FROM HAVING UPGRADES DONE. THE ISSUE OCCURRED DURING KIT INSPECTION AND THERE WAS NO PATIENT RELATED ISSUE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314817 ZIMMER AIR DERMATOME II HANDPIECE ZIMMER AIR DERMATOME II HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1