BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPUSDUO

    MDR report key: 699794 · Received April 13, 2006

    Report

    Report Number
    2914019-2006-00026
    Event Type
    Injury
    Date Received
    April 13, 2006
    Date of Event
    August 15, 2005
    Report Date
    April 13, 2006
    Manufacturer
    LUMENIS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE INCIDENT WAS REPORTED TO LUMENIS REGULATORY ON 03/16/2006. A DENTIST REPORTED THAT A SUBJECT REPORTED PAIN IN 08/2005 WHILE TREATED WITH THE ERBIUM: YAG WAVELENGTH OF THE OPUSDUO SYSTEM IN PREPARATION FOR A MINOR OCCLUSAL FILLING WITH A FLOWABLE COMPOSITE. ACCORDING TO THE CUSTOMER, FACTORY PRESETS FOR CLASS I CAVITY PREPARATION AND ENAMEL WERE UTILIZED. THE OPUSDUO OPERATOR MANUAL SPECIFIES 300-900 MJ ENERGY AND 7-20 PULSES PER SECOND PULSE RATE FOR THIS APPLICATION. TWO DIFFERENT DELIVERY DEVICES, THE 800 (HPX) AND 100 (HOLLOW OR HPX), WERE USED, BOTH IN CONTACT MODE. FOLLOWING THE PROCEDURE, THE SUBJECT CONTINUED TO EXPERIENCE DISCOMFORT, AND IN ABOUT 4 MONTHS LATER EMERGENCY PULPECTOMY WITH SEDATIVE FILL WAS PERFORMED TO ALLEVIATE PAIN. IN ABOUT A MONTH LATER, ROOT CANAL AND FILLING WERE COMPLETED. THE DENTIST STATED THAT PRIOR TO THE 08/2005 TREATMENT WITH THE OPUSDUO, THE TREATED TOOTH HAD ONLY A MINOR COSMETIC DEFECT (STAINING IN THE GROOVES) AND WAS OTHERWISE SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPUSDUO ERBIUM:YAG/ CARBON DIOXIDE SURGICAL LASER GEX LUMENIS GA5600000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention