BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLE POWER LUX CONTRA ANGLE 25LPR

    MDR report key: 3123939 · Received May 15, 2013

    Report

    Report Number
    3003637274-2013-00017
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 18, 2013
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DID SHOW THAT THE HANDPIECE RUNS OUT OF SPEC. FURTHER, THE BACK CAP BUTTON STICKS IN DUE TO DENTED HEAD. THIS CONDITION AFFECTED THE FUNCTIONALITY OF THE DRIVE AND THE BACK UP BUTTON. CAUSED BY INNER FRICTION THE HANDPIECE HEAT UP. THE CONDITION OF THE HANDPIECE INDICATES THAT THE MAINTENANCE PROCESSING IS NOT CARRIED OUT AS REQUESTED. THE USER INSTRUCTION REQUIRES A VISUAL AND FUNCTIONAL TEST PRIOR TO EACH TREATMENT TO ENSURE THAT THE HANDPIECE IS RUNNING WITHIN SPEC. IT CONTAINS ALSO A NOTE THAT THE HANDPIECE SHOULD NOT TOUCH SOFT TISSUE DURING THE TREATMENT. REPORTED DUE TO THE 2 YEAR PRESUMPTION RULE.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT ON TOOTH# 4, PT WAS BURNED AT CORNER LIP. THE BURN WAS APPROX THE SIZE OF THE BACK CAP OF AN HANDPIECE. NO OINTMENT OR MEDICATIONS MENTIONED IN CHART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215325 GENTLE POWER LUX CONTRA ANGLE 25LPR DENTAL HANDPIECE EFB KAVO DENTAL GMBH 25LPR

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR