BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASERSMILE

    MDR report key: 1354258 · Received March 30, 2009

    Report

    Report Number
    2027755-2009-00001
    Event Type
    Other
    Date Received
    March 30, 2009
    Date of Event
    December 20, 2008
    Report Date
    March 30, 2009
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) SPOKE TO DR. (B)(6) ON (B)(6) 2009. HE STATED THAT HE TREATED A PT (B)(6) OF 2008. SHE COMPLAINED OF INTENSE BURNING AND HE IMMEDIATELY STOPPED THE PROCEDURE. HE NOTICE BURNING PAST THE PALLET LINE. HE SENT HER HOME AND RECOMMENDED SHE USE DENTAL EEZE. HE FOLLOWED UP THE NEXT DAY AND SHE DESCRIBED "SLOUGHING SKIN" ON HER PALLET. HE CONTINUED TO FOLLOW UP AND SHE STOPPED RESPONDING. HE FEELS SHE HAS TOTALLY HEALED. SHE RECENTLY CONTACTED HIM AND STATED THAT HER CHRISTMAS WAS RUINED AND SHE WANTED THE NAME OF THE MFR. SHE SAID SHE WAS STARTING LITIGATION AGAINST HIM AND BIOLASE. HE WANTS TO HEAR FROM US ABOUT THIS ISSUE. I ASKED HIM IF HE HAS ANY REMAINING OF THAT GEL AND HE SAID THAT IT WAS DISPOSED. HE SAID THAT HE IS BUSY AT THIS TIME AND CAN NOT TALK TO ME ANYMORE AND HE HANDED THE PHONE TO HIS OFFICE MANAGER, (B)(6), AND SHE ASKED MY NAME AND TOLD ME THAT SHE WANTS TOT HEAR FROM US. I ASKED HER IF I CAN GET THE PATIENT'S NAME AND SHE SAID THAT SHE PREFERS TO GIVE INFORMATION TO COMPLAINT PERSONNEL. JUST A SIDE NOTE THAT THE LAST ORDER/PURCHASE FOUND IN BIOLASE SYSTEM IS (B)(6) 2008. CHECKED WITH (B)(6) (DISTRIBUTOR) AND FOUND DR. (B)(6) HAD NOT ORDERED/PURCHASED GEL SINCE (B)(6) 2008. GEL HAS A 6 MONTH SHELF LIFE SO IT APPEARS, AFTER ALL THE FACTS THAT THE DOCTOR WAS USING EXPIRED GEL WHEN ATTEMPTING PROCEDURE ON THIS PT. APPEARS GEL HAS BEEN EXPIRED FOR SEVEN (7) MONTHS AT THE TIME HE ATTEMPTED TO USE FOR THIS PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, DR. (B)(6) CALLED AND WANTED TO COMPLAINT ABOUT THE WHITENING GEL WHICH HE PURCHASE FROM US AND CAUSED INJURY TO HIS PATIENT. HE SAID THAT HE EXCLUSIVELY USES BIOLASE UNIT (WHICH BASED ON OUR RECORD IT IS A FIRST GENERATION LASERSMILE UNIT 7000120) FOR WHITENING AND HE HAS NOTICED THAT THE WHITENING GEL CONSISTENCY IS NOT LIKE BEFORE. HE SAID THAT IN THE PAST HE HAD ISSUE WITH THE WHITENING WHICH IT WAS RUNNY AND WOULD NOT MIX WELL AND HE ACTUALLY REPORTED (BUT IT COULD NOT FIND ANY CASE ABOUT THAT) BUT LAST (B)(6) (2009) HE WANTED TO PERFORM THE WHITENING AND WHEN HE SUED THE GEL SINCE IT WAS RUNNY; THE PURPLE GEL GOT INTO THE PT'S GUM AND IT BURNT HER GUM. HE DID NOT PERFORM THE PROCEDURE AND SHE LEFT THE OFFICE AND HE FOLLOWED UP ON HER BUT SHE COMPLAINED THAT SHE COULD NOT EAT FOR A WHILE AND SHE WAS IN SO MUCH PAIN. HE DID NOT HEAR FROM HER UNTIL HE GOT LETTER FROM HER ATTORNEY. HE SAID THAT HE NAMED OUR COMPANY AND OUR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASERSMILE SURGICAL DIODE LASER GEX BIOLASE TECHNOLOGY, INC. 7000120 NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention