BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX WINKELSTUCK 25LPA

    MDR report key: 2031992 · Received March 17, 2011

    Report

    Report Number
    3003637274-2011-00015
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 18, 2011
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A STANDARD PROCEDURE, A DENTAL ELECTRICAL HANDPIECE GOT HOT AND BURNED THE PT. THE LOCATION OF THE BURN IS NOT KNOW. PT RECEIVED SOME SAMPLES OF OINTMENT AND MEDICATION. THE ANALYSIS DID SHOW THAT THE HEAD IS DENTED AT THE BACKCAP. HENCE THE BACK CAP BUTTON STICKS IN AND CAUSES THE HEAD TO HEAT UP. EXEMPTION NUMBER (B)(4). KAVO DENTAL (B)(4) (THE MFR) IS SUBMITTING THE REPORT ON BEHALF OF KAVO DENTAL (B)(4) (THE IMPORTER).

    Description of Event or Problem · 1

    DURING A STANDARD PROCEDURE, A DENTAL ELECTRICAL HANDPIECE GOT HOT AND BURNED THE PT. THE LOCATION OF THE BURN IS NOT KNOW. PT RECEIVED SOME SAMPLES OF OINTMENT AND MEDICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other