BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX HANDPIECE 25LPA

    MDR report key: 1870759 · Received October 5, 2010

    Report

    Report Number
    1017522-2010-00026
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 16, 2010
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A DENTIST WAS PERFORMING A ROUTINE PROCEDURE ON A PT USING A DENTAL ELECTRIC HANDPIECE WHEN THE PT'S CHEEK WAS BURNED BY THE HEAD OF THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLEPOWER LUX HANDPIECE 25LPA DENTAL HANDPIECE EFB KAVO DENTAL GMBH 25LPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention