BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONRA ANGLE 25LPA

    MDR report key: 1812362 · Received August 16, 2010

    Report

    Report Number
    3003637274-2010-00024
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 2, 2010
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PATIENT WAS BURNED ON CHEEK TO THE SIZE OF A HANDPIECE BACK CAP. THE PATIENT WAS GIVEN PRESCRIPTION OINTMENT DEBACTEROL. DURING PRODUCT EVALUATION, LOW DEBRIS LEVELS WERE FOUND IN THE HANDPIECE. THE BEARINGS WHERE GRITTY AND THE HEAD WAS DAMAGED/DENTED. THE CAUSE FOR OVERHEATING WAS THE BACK CAP WHICH STICKS IN AND HEATS UP THE HEAD OF THE HANDPIECE. REMARK: A PATIENT WAS BURNED ON CHEEK, BUT DOCTOR COULD NOT DETERMINE WITH WHICH HANDPIECE THE PATIENT WAS BURNED. PLEASE CONSIDER THE POTENTIALLY AFFECTED HANDPIECE WE SUBMIT AS FOLLOW MDRS: FOR THE HANDPIECE 25 LPA - SERIAL # (B)(4) WAS FILED MDR 3003637274-2010-00023 AND FOR HANDPIECE 25LPA SERIAL # (B)(4) WAS FILED MDR 3003637274-2010-00024.

    Description of Event or Problem · 1

    A DENTIST WAS PERFORMING A ROUTINE PROCEDURE ON A PATIENT USING A DENTAL ELECTRIC HANDPIECE WHEN THE PATIENT'S CHEEK WAS BURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention