BEUDAMED
    FDA Adverse Event Summary report: N

    BIOLASE

    MDR report key: 456747 · Received April 29, 2003

    Report

    Report Number
    MW1028260
    Date Received
    April 29, 2003
    Date of Event
    November 1, 2002
    Report Date
    April 29, 2003
    Manufacturer
    BIOLASE
    Product Code
    LYB
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ROOT SURFACE OF TOOTH TREATED WITH DENTAL LASER APPEARED BROWN, POSSIBLE BURN TO ROOT. THIS COULD BE SEEN WITH A PERIOSCOPE. REPORTER HAS A COPY OF VIDEO. THIS OCCURRING DURING "LASER CURETTAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLASE DENTAL LASER LYB BIOLASE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA