BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 2241088 · Received August 17, 2011

    Report

    Report Number
    1526350-2011-00171
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE CUSTOMER THAT THE ZIMMER AIR DERMATOME WAS REPAIRED 6 MONTHS AGO FOR NOT WORKING CORRECTLY AND THE UNIT STILL WON'T TAKE SKIN EVENLY. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1