BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTAL POWER LUX CONTRA ANGLE

    MDR report key: 818741 · Received February 15, 2007

    Report

    Report Number
    1419798-2007-00003
    Event Type
    Injury
    Date Received
    February 15, 2007
    Date of Event
    November 15, 2006
    Report Date
    January 11, 2007
    Manufacturer
    KAVO AMERICA
    Product Code
    EKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR WAS INFORMED THAT THE HANDPIECE BEARINGS ARE WORN AND GRITTY. A SERVICE CHECK WAS RECOMMENDED TO EVALUATE IF IT WAS TIME FOR MAINTENANCE REPAIR. IN ADDITION, MAINTENANCE INFO WAS REVIEWED WITH THE DR.

    Description of Event or Problem · 1

    THE HEAD OF HANDPIECE BECAME HOT AND BURNED THE PT. THE INITIAL BURN CREATED A SMALL BLISTER. OINTMENT WAS APPLIED TO THE BURN. SHE HEALED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTAL POWER LUX CONTRA ANGLE * EKK KAVO AMERICA 25LPA *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention