BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 924922 · Received October 10, 2007

    Report

    Report Number
    1419798-2007-00024
    Event Type
    Injury
    Date Received
    October 10, 2007
    Date of Event
    August 30, 2007
    Report Date
    September 7, 2007
    Manufacturer
    KAVO AMERICA
    Product Code
    EKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MAINTENANCE INFORMATION WAS REVIEWED WITH THE OFFICE AND MAINTENANCE SHEETS WERE SENT. THE WATER SPRAY WAS CLOGGED WITH A PRESENCE OF LOW RESIDUE. THE BACK CAP WAS STUCK IN DUE TO DENTS IN THE HEAD OF THE HANDPIECE.

    Description of Event or Problem · 1

    THE HEAD OF THE HANDPIECE BECAME HOT AND CREATED A SMALL BURN TO THE BUCCAL MUCOSA CHEEK. PATIENT WAS PRESCRIBED PERIDEX MOUTH RINSE AND HAS COMPLETELY HEALED.

    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