BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLEPOWER LUX CONRA ANGLE 25LPA

    MDR report key: 1812460 · Received August 16, 2010

    Report

    Report Number
    3003637274-2010-00025
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 21, 2010
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER OF THE DENTAL HANDPIECE RECOGNIZED THE HP IS DEFECTIVE AND GETS HOT. THEREFORE, WAS NOT CAUSED ANY BURN OR OTHER INJURY. DURING PRODUCT EVAL, LOW DEBRIS LEVEL WERE FOUND IN THE HANDPIECE. THE BEARINGS WERE GRITTY AND THE HEAD WAS DAMAGED/DENTED. THE CAUSE FOR OVERHEATING IS THE DENTED HEAD AT THE BACK CAP OF THE HANDPIECE.

    Description of Event or Problem · 1

    A DENTIST PERFORMED A ROUTINE PROCEDURE ON A PT. DURING TREATMENT, THE DENTAL ELECTRIC HANDPIECE GOT HOT BUT CAUSED NO BURN OR ANY INJURY ON PT.

    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