BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 2882069 · Received December 17, 2012

    Report

    Report Number
    3003637274-2012-00063
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 21, 2012
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE HANDPIECE DID SHOW THAT THE BEARINGS HAVE BEEN GRITTY AND THE HEAD WAS DENTED CAUSING THE BACKCAP BUTTON TO STICK IN. THIS CAUSED UNUSUAL INNER FRICTION CAUSING THE HEAD TO HEAT UP. THE DENT INDICATED THAT THE HANDPIECE WAS DROPPED OR MISHANDLED, E.G. DURING REPROCESSING. THE CONDITION OF THE BEARING MIGHT BE A NORMAL WEAR ISSUE, BUT IT IS LIKELY THAT DUE TO THE DENT AND THE HIGH TEMPERATURE A STRONGER WEAR TOOK PLACE. THE USER INSTRUCTION REQUIRES A VISUAL AND FUNCTIONAL INSPECTION PRIOR TO EACH TREATMENT WHICH WOULD HENCE BE MANDATORY AND SHOW WHETHER PRODUCT IS RUNNING WITHIN SPECIFICATION. REPORTED DUE TO THE 2 YEAR PRESUMPTION RULE.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT ON THE LOWER BICUSPID THE HANDPIECE HEATED UP AND BURNED THE PT ON THE CHEEK TO HALF OF THE SIZE OF A DIME. HE WAS GIVEN SAMPLES OF PERIDEX RINSE AND KENALOG ORABASE. NO MEDICAL CARE WAS NECESSARY. THE DENTAL OFFICE DOES NOT RECALL THE NAME OF THE PT, THEREFORE THE AGE AND THE DATE OF EVENT CAN BE SUPPLIED ONLY APPROXIMATELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR