BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPR

    MDR report key: 4177329 · Received August 13, 2014

    Report

    Report Number
    3003637274-2014-00027
    Event Type
    Malfunction
    Date Received
    August 13, 2014
    Date of Event
    June 1, 2014
    Report Date
    July 15, 2014
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DID SHOW THAT THE HANDPIECE RUNS OUT OF SPECIFICATION. THE HEAD HEATS UP WHICH WAS CAUSED BY INNER FRICTION.

    Description of Event or Problem · 1

    DURING THE CALL WITH THE DENTAL OFFICE ON (B)(6) 2014 IT WAS STATED THAT A SECOND PERSON WAS BURNED WITH THE SAME HANDPIECE. IN THIS CASE THE HANDPIECE HEATED UP BURNING A STANDARD DENTAL TREATMENT AND CAUSED A BURN IN CHEEK. THE PT WAS GIVEN SOME OTC VITAMINE E COIL TO APPLY TO THE BURN. SEE ALSO MDR 3003637274-2014-00024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483326 GENTLEPOWER LUX CONTRA ANGLE 25LPR DENTAL HANDPIECE EFB KAVO DENTAL GMBH 25LPR

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR