BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX WINKELSTUCK 25LP

    MDR report key: 2092617 · Received May 9, 2011

    Report

    Report Number
    3003637274-2011-00028
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 12, 2011
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A STANDARD TREATMENT, A DENTAL ELECTRICAL HANDPIECE GOT HOT AND BURNED PATIENT ON CHEEK. THE ANALYSIS DID SHOW THAT THE HEAD HAD A DENT WHICH CAUSED THE BACKCAP BUTTON TO STICK IN. THIS CAUSED A LOT OF FRICTION AND AS A RESULT THE HEAD HEATED UP. ISSUE OCCURRED IN (B)(6) WITH SIMILAR DEVICE THAN DISTRIBUTED IN THE US.

    Description of Event or Problem · 1

    DURING A STANDARD TREATMENT, A DENTAL ELECTRICAL HANDPIECE GOT HOT AND BURNED PATIENT ON CHEEK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other