BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 1295142 · Received January 28, 2009

    Report

    Report Number
    1419798-2009-00002
    Event Type
    Injury
    Date Received
    January 28, 2009
    Date of Event
    December 23, 2008
    Report Date
    December 29, 2008
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NE, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    WHILE THE DENTIST WAS WORKING ON TOOTH #26 WITH THE 25LPA HANDPIECE, THE PATIENT'S CHEEK WAS BURNED ABOUT THE SIZE OF THE HANDPIECE BACK CAP.

    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