BEUDAMED
    FDA Adverse Event Other Summary report: N

    WHITENING GEL

    MDR report key: 2794991 · Received October 3, 2012

    Report

    Report Number
    1718912-2012-00005
    Event Type
    Other
    Date Received
    October 3, 2012
    Date of Event
    August 24, 2012
    Report Date
    October 3, 2012
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Product Code
    EJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B)(6) CALLED BECAUSE SHE WANTED AN INGREDIENT LIST FOR VW MAX AND GINGIVAL BATTIER. SHE SAID THAT DR (B)(6) DAUGHTER WENT TO ANOTHER OFFICE FOR WHITENING. SHE SAID THAT THEY ARE AN ORTHODONTIC OFFICE, BUT HER FRIEND, A FELLOW ORTHODONTIST, DOES THE IN-OFFICE WHITENING. THE PT WENT TO THE OFFICE AND HAD THE TREATMENT ON THURSDAY. I ASKED TO GET THE OTHER OFFICE INFO. SHE SAID THAT THEY DID NOT WANT TO PROVIDE THIS INFO. SHE SAID THAT SHE HAD ASKED AND THAT THEY HAD APPLIED THE BARRIER, LIGHT CURED, HAD PLACED THE STANDARD ORTHO CHEEK RETRACTORS. THEN THEY PROCEEDED WITH THE WHITENING. THEY DID 2 TO 3, 12 - 15 MINUTE APPLICATIONS, RINSED, AND USED A STANDARD ORTHO EVACUATION TIP TO SUCTION. SHE SAID THAT THERE WAS SOME HALOING OF THE GINGIVA UPON REMOVAL OF THE GINGIVAL BARRIER. SHE SAID THAT THEY GENERALLY SEE THIS AND THE PT WAS INFORMED AND TOLD THAT IT WOULD DISAPPEAR BY MORNING. SHE SAID THAT ON THE MORNING OF (B)(6) 2012, THE PT WOKE UP WITH SWOLLEN, RED, BLEEDING GUMS. SHE SAID THE GINGIVA WAS BLEEDING ON THE MAXILLARY AND MANDIBULAR FROM FIRST MOLAR TO FIRST MOLAR. SHE SAW A PHYSICIAN WHO SAID THAT IT APPEARED TO BE AN ALLERGIC REACTION. SHE HAS NOT BEEN ABLE TO COMFORTABLY EAT DUE TO THE EXTREME INFLAMMATION OF HER GUMS. SHE HAS IMPECCABLE ORAL HYGIENE AND NORMALLY VERY HEALTHY GUM TISSUE. SHE HAS BEEN TAKING BENADRYL SINCE FRIDAY EVENING. SHE SAID THAT THE PT HAS BEEN DOING WARM SALT WATER RINSES 2 TIMES A DAY. SHE SAID THAT SHE WILL REMAIN ON THE BENADRYL UNTIL WE CAN PROVIDE FURTHER INFO BEFORE CONSULTING WITH OTHER MEDICAL PRACTITIONER. SHE SAID THAT THE PT HAS NOT NOTICED ANY TOOTH SENSITIVITY. I ADVISED THAT THE PT SEE AN ALLERGIST AND SAID THAT I WOULD SEND A VW MAX KIT FOR TESTING. SHE ASKED IF WE COULD SEND A TAKE HOME KIT FOR TESTING, AS THE PT WANTS TO TRY THIS, IF POSSIBLE, AND WOULD LIKE TO TAKE THIS TO THE ALLERGIST ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITENING GEL IN OFFICE BLEACH EJK ULTRADENT PRODUCTS, INC. 40005240

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other