BEUDAMED
    FDA Adverse Event Other Summary report: N

    557CX ULTRALITE SWIVEL HANDPIECE

    MDR report key: 2018243 · Received March 7, 2011

    Report

    Report Number
    2916440-2011-00001
    Event Type
    Other
    Date Received
    March 7, 2011
    Date of Event
    January 6, 2011
    Report Date
    March 3, 2011
    Manufacturer
    LARES RESEARCH, INC.
    Product Code
    EFB
    PMA / PMN Number
    K780038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DENTIST CALLED AND REPORTED THAT THE HIGH-SPEED DENTAL HANDPIECE BURNED THE PATIENT'S LIP DURING A PROCEDURE. NO MEDICAL INTERVENTION WAS REPORTED BY CUSTOMER OR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 557CX ULTRALITE SWIVEL HANDPIECE HIGH-SPEED AIR HANDPIECE EFB LARES RESEARCH, INC. 557CX

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other