BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLE POWER LUX CONTRA ANGLE 25LPA

    MDR report key: 3123996 · Received May 15, 2013

    Report

    Report Number
    3003637274-2013-00014
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DID SHOW VERY HEAVY RESIDUE IN THE HANDPIECE, THE BEARING WAS STIFF. THE STIFF BEARING CAUSED HIGH FRICTION AND THEREFORE INCREASE OF TEMPERATURE. 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, WHILE WORKING ON TOOTH #30 THE PT WAS BURNED ON THE TONGUE. THE BURN IS ABOUT 4-5 MM. NOTHING WAS PRESCRIBED OR GIVEN TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214978 GENTLE POWER LUX CONTRA ANGLE 25LPA DENTAL HANDPIECE EFB KAVO DENTAL GMBH 25LPA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR