BEUDAMED
    FDA Adverse Event Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 4131254 · Received September 17, 2014

    Report

    Report Number
    3003637274-2014-00034
    Date Received
    September 17, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 2, 2014
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DID SHOW THAT A HEAVY RESIDUE WAS INSIDE THE HANDPIECE. THIS CAUSES A STRONGER WEAR OF THE BEARINGS. THE BEARINGS HAVE BEEN VIBRATING AND FALLING APART. HEAT UP WAS REPRODUCIBLE. ROOT CAUSE FOR THE RESIDUE IS THAT THE HANDPIECE GETS NOT MAINTAINED AS REQUESTED BY USER INSTRUCTIONS.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT THE HEAD OF THE HANDPIECE HEATED UP AND BURNED THE PT ON A CHEEK TO THE SIZE OF A DIME. PT WAS TOLD TO DO WARM/SALT WATER RINSES, NO MEDICAL CARE WAS NECESSARY. FURTHER DATA OF PT ARE NOT KNOWN. TWO PATIENTS HAVE BEEN BURNED WITH THIS HANDPIECE, SEE ALSO MDR #3003637274-2014-00033.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577131 GENTLEPOWER LUX CONTRA ANGLE 25LPA DENTAL HANDPIECE EFB KAVO DENTAL GMBH 25LPA

    Patients

    Seq Age Sex Outcome Treatment
    1