BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTALPOWER LUX CONTR ANGLE

    MDR report key: 818739 · Received February 15, 2007

    Report

    Report Number
    1419798-2007-00002
    Event Type
    Injury
    Date Received
    February 15, 2007
    Date of Event
    January 16, 2007
    Report Date
    January 18, 2007
    Manufacturer
    KAVO AMERICA
    Product Code
    EKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR WAS INFORMED THAT THERE WAS A DENT IN THE EDGE OF THE HEAD OF THE HANDPIECE THAT CAUSED THE HEAD TO HEAT UP. IN ADDITION, MAINTENANCE INFO AND SETTINGS WERE REVIEWED WITH THE DR. MAINTENANCE SHEETS WERE SENT.

    Description of Event or Problem · 1

    THE HEAD OF THE HANDPIECE BECAME HOT AND BURNED THE PT. ANTI-INFLAMMATORY GEL WAS APPLIED TO THE BURN. HE HEALED FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention