BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME KIT

    MDR report key: 2041968 · Received March 31, 2011

    Report

    Report Number
    1526350-2011-00050
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    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 FOR REPAIR. THE SVC RECORD INDICATES THAT THE DEVICE WAS MFG ON (B)(6) 2010. A VISUAL AND FUNCTIONAL INSPECTION OF THE DEVICE COULD NOT FIND ANY PROBLEMS WITH THE UNIT. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. DEVICE PASSED ALL PERFORMANCE TESTING REQUIREMENTS. ALL CALIBRATIONS WERE WITHIN SPECIFICATION. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME LACKED POWER AND REQUIRED THE SURGEON TO TAKE ADD'L PIECES OF SKIN TO COMPLETE THE CASE.

    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