BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 2844241 · Received November 8, 2012

    Report

    Report Number
    1526350-2012-00285
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    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 INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER DERMATOME WAS SKIPPING. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.

    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