BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIOLASE PLUS

    MDR report key: 589134 · Received March 28, 2005

    Report

    Report Number
    2027755-2005-00001
    Event Type
    Injury
    Date Received
    March 28, 2005
    Report Date
    March 4, 2005
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTIST'S OFFICE PERFORMED A PERIODONTAL PROCEDURE IN THE BEGINNING OF FEBRUARY. THE PROCEDURE INVOLVED LASER TREATMENT OF A 7MM DEEP POCKET AT THE 31 DISTAL POSTITION. AFTER THE PROCEDURE, THE PATIENT WAS SENT HOME WITH A STANDARD TREATMENT REGIMENT (IBUPROFEN PLUS SALTWATER WASHES). THE FOLLOWING DAY, THE PATIENT REPORTED SIGNIFICANT PAIN AND RETURNED TO THE DENTIST. ACCORDING TO THE DENTIST AND HYGIENIST, THE PATIENT HAD A HOLE IN PATIENT'S GUM TISSUE AT THE THE LOCATION OF THE PREVIOUS DAY'S TREATMENT, ABOUT 4-5 MM ACROSS. 4-5 MM ALONG THE SIDE OF THE PATIENT'S TOOTH AND 5-6 MM DEEP. AT THE BOTTOM OF THIS HOLE, THE PATIENT'S BONE AT THE BOTTOM OF THE HOLE WAS DEAD. THE PATIENT WAS GIVEN ANTIBIOTICS AND PAIN MEDICATION. THE DENTIST'S USUAL LASER SETTINGS FOR THIS PROCEDURE ARE A MAXIMUM POWER OUTPUT OF 1 WATT, CONTINUOUS WITH TREATMENT FOR NO MORE THAN 20 TO 30 SECONDS. THESE SETTINGS ARE CONSISTENT WITH TYPICAL CLINICAL PRACTICE. BIOLASE BELIEVES THE REPORTED CLINICAL OUTCOME IN THIS EVENT IS CONSISTENT WITH A MUCH HIGHER POWER SETTING AND/OR A MUCH LONGER EXPOSURE TIME THAN THE DENTIST'S USUAL SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIOLASE PLUS SURGICAL DIODE LASER GEX BIOLASE TECHNOLOGY, INC. 7000694 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention