BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 1232923 · Received November 18, 2008

    Report

    Report Number
    8010493-2008-00023
    Event Type
    Injury
    Date Received
    November 18, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 7, 2008
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS PRESCRIBED KENALOG OINTMENT FOR TREATMENT OF BURN TO LIP. AT THE HANDPIECE EVALUATION, IT WAS FOUND THAT THE BEARINGS WERE WORN AND GRITTY IN DRIVE ASSEMBLY, SHAFT, AND AXLE, AND THE WATER PORT WAS CLOGGED. MEDIUM DEBRIS LEVEL WAS PRESENT. PROPER MAINTENANCE WAS DISCUSSED WITH THE OFFICE AND A TWO-YEAR SERVICE CHECK WAS SUGGESTED. THE HANDPIECE WAS REPAIRED.

    Description of Event or Problem · 1

    WHILE THE DENTIST WAS WORKING ON TOOTH #1, #2 AND #30, THE PATIENT'S LOWER LIP WAS BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLEPOWER LUX CONTRA ANGLE 25LPA DENTAL HANDPIECE AND ACCESSORIES EFB KALTENBACH & VOIGT GMBH 25LPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention