BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 2163450 · Received July 6, 2011

    Report

    Report Number
    3003637274-2011-00042
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 17, 2011
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A STANDARD TREATMENT, AN ELECTRICAL DENTAL HANDPIECE GOT HOT AND CAUSED A BURN ON LOWER LIP. THE BURN DIAMETER WAS THE SIZE OF THE BACK CAP. THE PATIENT WAS PRESCRIBED ORABASE. THE ANALYSIS DID SHOW THAT THE HEAD OF THE HANDPIECE HAD A DENT AT SPRAY INSERT AND AT THE BACK CAP. THIS DENT CAUSED THE BACK CAP TO STICK IN AND HENCE THE HEAD TO HEAT UP. EXEMPTION NUMBER (B)(4). KAVO DENTAL (B)(4) (THE MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4).

    Description of Event or Problem · 1

    DURING A STANDARD TREATMENT, AN ELECTRICAL DENTAL HANDPIECE GOT HOT AND CAUSED A BURN ON LOWER LIP. THE BURN DIAMETER WAS THE SIZE OF THE BACK CAP. PATIENT WAS PRESCRIBED ORABASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention