BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3169320 · Received June 5, 2013

    Report

    Report Number
    1526350-2013-00290
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 06/24/2002 AND WAS LAST REPAIRED ON (B)(4) 2012. EVALUATION OF THE DEVICE OBSERVED THAT THE HEAD, CONTROL BAR AND ALL FOUR WIDTH PLATES, 1", 2", 3" AND 4", WERE DAMAGED. THE END OF THE AIR HOSE WAS ALSO DETERMINED TO BE DENTED. PRIOR TO REPAIR, THE DEVICE WAS OUT OF CALIBRATION AT THE ZERO, 0.01 AND 0.02 THICKNESS SETTINGS ON THE LEFT SIDE. THE DEVICE WAS ALSO OUT OF SIDE TO SIDE CALIBRATION AT THE ZERO THICKNESS SETTING. THE CAUSE IS LIKELY THE USER NOT MAINTAINING THE DEVICE PER IMPROPER HANDLING. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS PRODUCING BAD GRAFTS. ADDITIONAL CLINICAL FOLLOW UP WITH THE REPORTED REVEALED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249505 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1