BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASERWHITE 20 WHITENING GEL

    MDR report key: 1994615 · Received February 8, 2011

    Report

    Report Number
    2027755-2011-00001
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS SOON AS WE RECEIVED THE LETTER AND THE PRODUCT, WE CONTACTED THE DENTAL OFFICE "USER FACILITY" TO FURTHER INVESTIGATE. WE TALKED TO THE DENTAL ASSISTANT "(B)(6)" WHO ACTUALLY PERFORMED THE TEETH WHITENING ON THE PT. SHE INDICATED THAT SHE WAS TRAINED BY THE DENTIST AND THE DENTIST WAS TRAINED USING (B)(4) ON LINE TRAINING COURSE. SHE INDICATED THAT THIS IS HER FIRST TIME USING THE DEVICE FOR WHITENING. SHE ALSO INDICATED THAT THE LASER SYSTEM WAS NOT EVEN FIRED TO START THE WHITENING PROCESS. THE WHITENING GEL INSTRUCTIONS FOR USE WERE THOROUGHLY REVIEWED AND FOUND TO BE ADEQUATE. THE USER IS INSTRUCTED TO PROTECT THE PT'S GUM AND LIPS USING THE LIQUID DAM SUPPLIED IN THE KIT, VASELINE, AND COTTON BALLS. EVAL OF THE RETURNED PRODUCT WAS ALSO PERFORMED: THE RETURNED LASER HANDPIECE WAS FUNCTIONALLY TESTED AND FOUND WITHIN SPEC. ONE OF THE RETURNED WHITENING GEL KITS WAS SEND TO THE MFR FOR FURTHER ANALYSIS. THE WHITENING GEL DEVICE HISTORY RECORD WAS ALSO REVIEWED AND FOUND THAT ALL KITS PASSED THE FINAL ACCEPTANCE TESTING AT THE POINT OF RELEASE. THE DENTAL ASSISTANCE WAS INSTRUCTED TO FOLLOW THE INSTRUCTIONS SUPPLIED WITH EACH KIT. WE ALSO ASKED ABOUT THE CONDITION OF THE PT, THE DENTAL ASSISTANT INDICATED THAT THE PT IS FINE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, WE RECEIVED A LETTER FROM DR. (B)(6) DENTAL OFFICE INDICATING THAT ONE OF THEIR PATIENTS EXPERIENCED PAIN WHEN THE LASERWHITE 20 WHITENING GEL WAS USED FOR TEETH WHITENING. DR. (B)(6) ALSO REPORTED THAT THE WHITENING GEL BURNED THE PT'S GUM AND SHE BROKE OUT WITH WHITE BUBBLES ALONG HER MOUTH. THE FOLLOWING PRODUCTS WERE RETURNED WITH THE LETTER: 4-KITS OF LASERWHITE 20 WHITENING GEL. WHITENING HANDPIECE OF THE DENTAL LASER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASERWHITE 20 WHITENING GEL LASERWHITE 20 GEX BIOLASE TECHNOLOGY, INC. NA B5JZY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA