BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 1153485 · Received September 5, 2008

    Report

    Report Number
    1419798-2008-00014
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 13, 2008
    Manufacturer
    KALTENBACK & VOIGT GMBH
    Product Code
    EFA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PT'S CHEEK WAS BURNED BY THE HANDPIECE WHEN IT WAS USED AS A CHEEK RETRACTOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention