BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 1980145 · Received January 31, 2011

    Report

    Report Number
    1526350-2011-00017
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. THE SERVICE RECORDS INDICATE THE DEVICE IS GREATER THAN TEN YEARS OLD. THE LAST REPAIR WAS ON (B)(6) 2010, FOR A NON RELATED ISSUE. A VISUAL INSPECTION FOUND THE DEVICE HAD MINOR SCRATCHES ON THE LEADING EDGES OF THE HEAD AND CONTROL BAR. IN ADDITION, THE DEVICE WAS FOUND TO BE OUT OF CALIBRATION ON THE ZERO GRAFT ABILITY. THE EXACT CAUSE OF THE REPORTED ISSUE WAS UNABLE TO BE DETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS CUTTING TOO DEEP. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL ON (B)(6) 2011, INDICATED THAT THE EVENT INVOLVED AN ELDERLY PATIENT WITH POOR SKIN TURGOR. THE INITIAL DEPTH SETTING WAS AT 14 WHICH WAS LATER FELT TO BE TOO THICK. THE DEVICE HARVESTED A FULL THICKNESS SKIN GRAFT WITH FAT. THE FAT LAYER WAS SURGICALLY REPAIRED WITH SUTURE. THERE WAS NO ADDITIONAL GRAFT HARVEST REQUIRED.

    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