BEUDAMED
    FDA Adverse Event Other Summary report: N

    WATERLASE MD SOFT AND HARD TISSUE LASER

    MDR report key: 1368343 · Received December 9, 2008

    Report

    Report Number
    2027755-2007-00004
    Event Type
    Other
    Date Received
    December 9, 2008
    Date of Event
    November 13, 2008
    Report Date
    December 7, 2008
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Product Code
    GEX
    PMA / PMN Number
    K030523
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK AT THIS TIME WHAT THE TRUE CAUSE OF THE EVENT WAS. FURTHER CONTACT WAS MADE TO THE DOCTOR FOR INFO BUT NO RESPONSE WAS RECEIVED.

    Description of Event or Problem · 1

    ON (B) (6) 2008, DR (B) (6) CALLED BIOLASE TECHNOLOGY SERVICE HOTLINE FOR PT EMERGENCY AND APPLICATION ASSISTANCE. DR (B) (6) WAS REPORTING A SOFT TISSUE (EXCISION OF PERIOCORONAL GINGIVAL) PROCEDURE AT WHICH TIME SHE WAS USING A DRILL AND SWITCHING TO THE LASER. THE PT, A (B) (6) BOY, HAD A REACTION IN WHICH HIS FACE SWELLED UP CAUSING THE DOCTOR TO HAVE TO CALL 911 AND THE PT HAVING TO BE TAKEN TO THE HOSPITAL BY AMBULANCE. AFTER COMMUNICATIONS BETWEEN THE DOCTOR AND BIOLASE STAFF THE TRUE CAUSE OF THE EVENT CANNOT BE DETERMINED. THE ONLY DETERMINATION MADE WAS THE PT SUFFERED FROM AIR EDEMA AROUND TOOTH NUMBER #31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WATERLASE MD SOFT AND HARD TISSUE LASER WATERLASE MD GEX BIOLASE TECHNOLOGY, INC. 6200218

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization