BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 2405703 · Received December 7, 2011

    Report

    Report Number
    3003637274-2011-00067
    Event Type
    Malfunction
    Date Received
    December 7, 2011
    Date of Event
    November 9, 2011
    Report Date
    November 10, 2011
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A) DURING A STANDARD TREATMENT, AN ELECTRICAL DENTAL HANDPIECE GOT HOT AND BURNED THE PT ON THE TONGUE AND LOWER LIP. TONGUE HAD A VERY SMALL BURN, LIP WAS BURNED TO THE SIZE OF THE BACK CAP. PT WAS TOLD TO TAKE OTC-IBUPROFEN AND WAS INSTRUCTED TO APPLY ICE TO LIP AS NEEDED. PT WAS CONTACTED ONE DAY AFTER AND SHE STATED THAT SHE WAS FEELING WELL. B) THE ANALYSIS OF THE HANDPIECE DID SHOW THAT IT HAD A MEDIUM DEBRIS LEVEL. THE BEARINGS HAVE BEEN GRINDING, WOBBLING AND FALLING APART. THE HEAD HEATED UP DURING TEST RUN OF THE EVAL. THE USER INSTRUCTION REQUIRES A TEST RUN BEFORE EACH USE AND INFORMS THAT A HANDPIECE MUSTN'T BE USED IF IT RUNS OUT OF SPECIFICATIONS. C) REPORTED DUE TO THE 2 YEAR PRESUMPTION RULE.

    Description of Event or Problem · 1

    DURING A STANDARD TREATMENT, AN ELECTRICAL DENTAL HANDPIECE GOT HOT AND BURNED THE PT ON TONGUE AND LOWER LIP. TONGUE HAD A VERY SMALL BURN, LIP WAS BURNED TO THE SIZE OF THE BACK CAP. PT WAS TOLD TO TAKE OTC-IBUPROFEN AND WAS INSTRUCTED TO APPLY ICE TO LIP AS NEEDED. PT WAS CONTACTED ONE DAY AFTER AND SHE STATED THAT SHE WAS FEELING WELL.

    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 28 YR