BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWR LUX CONTRA ANGLE 25LPA

    MDR report key: 2971237 · Received June 20, 2007

    Report

    Report Number
    1419798-2007-00018
    Event Type
    Injury
    Date Received
    June 20, 2007
    Date of Event
    April 30, 2007
    Report Date
    May 15, 2007
    Manufacturer
    KAVO AMERICA
    Product Code
    EFB
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MAINTENANCE INFO WAS REVIEWED WITH THE OFFICE AND MAINTENANCE SHEETS WERE SENT. HEAD, COVER NUT AND BACK END CAP ARE DAMAGED DUE TO DENTS AT 10 AND 12, BEARINGS/GEARS ARE WORN AND GRITTY IN DRIVE ASSEMBLY AND SHAFT DUE TO THE DENTS. DENTS IN HEAD CAUSES ATTACHMENT TO HEAT UP, THERE WAS MEDIUM AMOUNT OF DEBRIS FOUND IN UNIT.

    Description of Event or Problem · 1

    THE HANDPIECE BECAME HOT AND BURNED THE PT'S TONGUE. ONE PART MAALOX, ONE PART BENADRYL ELIXIR AND ONE PART XYLOCAINE VISCUS WAS PRESCRIBED AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLEPOWR LUX CONTRA ANGLE 25LPA OPERATIVE DENTAL UNIT ACCESSORY EFB KAVO AMERICA 25LPA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK