BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME KIT

    MDR report key: 2092955 · Received April 20, 2011

    Report

    Report Number
    1526350-2011-00061
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS SKIPPING. ADD'L CLINICAL FOLLOW UP ON (B)(6) 2011 INDICATED THAT THE DEVICE WAS REPLACED IMMEDIATELY UPON FIRST SKIP WITH NO HARM TO PT, NO ADD'L GRAFT TISSUE HARVESTED, NO DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1