BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSEMASTER

    MDR report key: 196972 · Received November 13, 1998

    Report

    Report Number
    1646420-1998-00001
    Event Type
    Injury
    Date Received
    November 13, 1998
    Date of Event
    July 9, 1998
    Report Date
    November 13, 1998
    Manufacturer
    AMERICAN DENTAL TECHNOLOGIES
    Product Code
    GEX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DENTIST (GENERAL PRACTITIONER) USED A DENTAL LASER TO PERFORM A MAXILLARY FRENECTOMY ON A YOUNG GIRL (WHO WAS ALSO UNDERGOING ORTHODONTIC TREATMENT BY THE SAME DENTIST), USING THE PROCEDURAL PROTOCOLS AND CONTROL PANEL SETTINGS RECOMMENDED BY THE MFR. LOCAL ANESTHESIA WAS ADMINISTERED PRIOR TO THE FRENECTOMY PROCEDURE WHICH WAS PERFORMED UNEVENTFULLY. SUTURES WERE PLACED. AFTERWARD, THE PT APPEARED FINE AND WAS DISMISSED. AT THREE-WEEK F/U, THE PT'S LABIAL PLATE WAS STILL EXPOSED, NOW PURULENT AND EXUDATIVE. ANTIBIOTICS WERE PRESCRIBED. TWO WEEKS LATER, EXMINATION SHOWED ONLY A LIGHTLY IMPROVED CONDITION. ANOTHER REGIMEN OF ANTIBIOTICS WAS PRESCRIBED. CLINICAL EXAMINATION TWO WEEKS LATE SHOWED LITTLE IMPROVEMENT WITH EVIDENCE OF EXFOLIATING BONE TISSUE. THE DENTIST REFERRED THE PT TO A PERIODONTIST WHO UPON EXMINATION OF THE PERIOSTEUM REPORTED TWO SMALL VERTICAL TROUGHS WITH BONE DEGENERATION AND EXFOLIATION. THE PERIODONTIST CLEANED OUT THE EXFOLIATED AREA AND THEN PERFORMED TWO SLIDING PEDICLE GRAFTS. CURRENTLY THE PT IS UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSEMASTER PULSED ND: YAG DENTAL LASER GEX AMERICAN DENTAL TECHNOLOGIES 600 LE *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention