BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 839572 · Received April 12, 2007

    Report

    Report Number
    1419798-2007-00014
    Event Type
    Injury
    Date Received
    April 12, 2007
    Date of Event
    March 21, 2007
    Report Date
    April 11, 2007
    Manufacturer
    KAVO AMERICA
    Product Code
    EKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    HEAD IS DAMAGED DUE TO MULTIPLE DENTS BEARINGS/ GEARS ARE WORN AND GRITTY IN DRIVE ASSEMBLY AND SHAFT HAD HEAVY DEBRIS. MAINTENANCE INFORMATION WAS REVIEWED WITH THE DOCTOR AND MAINTENANCE SHEETS WERE SENT.

    Description of Event or Problem · 1

    THE HANDPIECE BECAME HOT AND BURNED THE PATIENT LIP. THE BURNS WERE SLIGHTLY LARGER THAN HANDPIECE HEAD. OINTMENT WAS APPLIED TO THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLEPOWER LUX CONTRA ANGLE 25LPA OPERATIVE DENTAL UNIT ACCESSORY EKK KAVO AMERICA 25LPA *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention