BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 1061859 · Received June 12, 2008

    Report

    Report Number
    1419798-2008-00009
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 15, 2008
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Product Code
    EKK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    HANDPIECE BECAME HOT AND BURNED PT'S CHEEK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention