BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 2387901 · Received December 21, 2011

    Report

    Report Number
    3003637274-2011-00070
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 28, 2011
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A STANDARD TREATMENT OF AN ELECTRICAL DENTAL HANDPIECE GOT HOT AND BURNED THE CHEEK ON THREE SPOTS TO THE SIZE OF THE BACKCAP. THE PATIENT GOT SOME OTC SAMPLES OF OXYFRESH ALOE GEL. THE ANALYSIS OF THE HANDPIECE DID SHOW THAT THE HEAD WAS DENTED AT THE BACK CAP CAUSING THE BACK CAP TO STICK IN. AS A RESULT IT INTERFERES WITH MOVING PARTS CAUSING THE HEAD TO HEAT UP. ALSO THE BEARINGS HAVE BEEN GRITTY AND THE WATER SPRAY WAS POOR. THE USER INSTRUCTION REQUIRES A TEST RUN BEFORE EACH USE AND INFORMS THAT A HANDPIECE MUST NOT BE USED IF IT RUNS OUT OF SPECIFICATIONS. REPORTED DUE TO THE TWO YEAR PRESUMPTION RULE.

    Description of Event or Problem · 1

    DURING A STANDARD TREATMENT, AN ELECTRICAL DENTAL HANDPIECE GOT HOT AND BURNED THE CHEEK ON THREE SPOTS TO THE SIZE OF THE BACKCAP. THE PATIENT GOT SOME OTC SAMPLES OF OXYFRESH ALOE GEL.

    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