BEUDAMED
    FDA Adverse Event Other Summary report: N

    DLASE 300 PLUS

    MDR report key: 19097 · Received October 26, 1994

    Report

    Report Number
    1833683-1994-00001
    Event Type
    Other
    Date Received
    October 26, 1994
    Report Date
    September 30, 1994
    Manufacturer
    SUNRISE TECHNOLOGIES
    Product Code
    LYB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 9/21/94,DR. ST A DR. ORALLY REPORTED A FEMALE PT OF HIS SUFFERED A LOSS OF TWO TEETH. THE DR. STATED THAT A DENTAL LASER HAD BEEN USED FOR TISSUE RETRACTION AND FOR TREATMENT OF A CYST. THERE IS INSUFFICIENT INFORMATION DIRECTLY RELATING THE LOSS OF THE TWO TEETH TO USE OF THE LASER. HOWEVER, THIS REPORT IS BEING MADE BECAUSE A LASER WAS USED AS A PART OF THE PT'S TREATMENT. THE DR. DID NOT RELATE THE TOOTH LOSS TO HIS USE OF THE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLASE 300 PLUS DENTAL LASER LYB SUNRISE TECHNOLOGIES DLASE 300 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other