BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 1349192 · Received March 24, 2009

    Report

    Report Number
    1419798-2009-00004
    Event Type
    Injury
    Date Received
    March 24, 2009
    Report Date
    January 11, 2008
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE HANDPIECE HEATED UP AND A PATIENT WAS BURNED ON THE CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLEPOWER LUX CONTRA ANGLE 25LPA DENTAL HANDPIECE AND ACCESSORIES EFB KALTENBACH & VOIGT GMBH 25LPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention