BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORTDRIVE 200XDR

    MDR report key: 2882097 · Received December 17, 2012

    Report

    Report Number
    3003637274-2012-00065
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 26, 2012
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K080677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE HANDPIECE DID SHOW THAT THE HEAD HAD A DENT. THIS CAUSED THE BACK CAP BUTTON TO STICK IN, CAUSING UNUSUAL INNER FRICTION, CAUSING FINALLY THE HEAD TO HEAT UP. THE DENT INDICATES THAT THE HANDPIECE RECEIVED A STRONG HIT, E.G. A DROP DURING THE REPROCESSING. ALSO THE BEARINGS HAVE BEEN GRITTY. IT IS LIKELY THAT THIS IS THE RESULT OF A STRONGER WEAR PROCESS DUE TO THE HIGH TEMPERATURES. THE USER INSTRUCTION REQUIRES A VISUAL AND FUNCTIONAL TEST PRIOR TO EACH TREATMENT TO ENSURE PRODUCT IS WITHIN SPECIFICATION, WHICH WOULD HENCE BE MANDATORY. REPORTED DUE TO THE 2 YEAR PRESUMPTION RULE.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT THE HANDPIECE GOT HOT AND BURNED THE PT ON CHEEK APPROXIMATELY TO THE SIZE OF THE HANDPIECE HEAD. PT WAS GIVEN SOME SAMPLES OF KENOLOG ORABASE OINTMENT. NO MEDICAL CARE WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORTDRIVE 200XDR DENTAL HANDPIECE EFB KAVO DENTAL GMBH 200XDR

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR