BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 4098987 · Received September 4, 2014

    Report

    Report Number
    3003637274-2014-00028
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE HANDPIECE HAS NOT BEEN SENT IN FOR AN EVALUATION AN ANALYSIS HAS NOT BEEN PERFORMED. BUT THE DENTIST STATED THAT HE MIGHT HAVE USED THE HANDPIECE AS A CHEEK RETRACTOR. THIS CAUSES UNUSUAL INNER FRICTION AND THEREFORE THE HEAT UP OF THE HEAD AS THE PUSH BUTTON GETS PRESSED. KAVO RECOMMENDS TO SET UP A SERVICE INTERVAL FOR A LICENSED SHOP TO CLEAN, SERVICE AND CHECK THE FUNCTION OF THE MEDICAL DEVICE. THIS SERVICE INTERVAL DEPENDS ON THE FREQUENCY OF USE AND SHOULD BE ADJUSTED ACCORDINGLY. REPORTED DUE TO THE 2 YEAR PRESUMPTION RULE.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT THE HEAD OF THE HANDPIECE HEATED UP AND BURNED THE PATIENT ON CHEEK TO THE SIZE OF A DIME. PATIENT RECEIVED SOME OTC VITAMIN E ALOE OINTMENT TO APPLY TO BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539776 GENTLEPOWER LUX CONTRA ANGLE 25LPA DENTAL HANDPIECE EFB KAVO DENTAL GMBH 25LPA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR