BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOR TEETH DESENSITIZER

    MDR report key: 4959534 · Received July 30, 2015

    Report

    Report Number
    3010407924-2015-00013
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    June 26, 2015
    Report Date
    June 30, 2015
    Manufacturer
    EVOLVE DENTAL TECHNOLOGIES INC.
    Product Code
    KLE
    PMA / PMN Number
    K953405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LIKELY ALLERGIC REACTION TO THE HEMA IN THE DESENSITIZER.

    Description of Event or Problem · 1

    DENTIST OFFICE CALLED, STATED THE PATIENT CALLED THEM ON MONDAY ((B)(6) 2015) AND SAID WHEN SHE WOKE UP AFTER HER SECOND NIGHT OF CONSECUTIVE AT HOME WHITENING ((B)(6) 2015), HER BOTTOM LIP WAS SWOLLEN, AND SHE HAD SORES ALONG THE INSIDE OF HER MOUTH. DENTIST ADVISED THE PATIENT TO DISCONTINUE USE OF THE KOR DESENSITIZER ON MONDAY, AFTER THE PATIENT FIRST CALLED IN. THE PATIENT CALLED IN AGAIN ON ((B)(6) 2016) AND SAID THAT THE SWELLING AND SORES HAVE NOT REALLY IMPROVED SINCE FRIDAY. EVOLVE STAFF INFORMED OFFICE TO ADVISE THE PATIENT TO SEE HER GENERAL PRACTITIONER TO HELP WITH THE SYMPTOMS. AFTER SEVERAL ATTEMPTS, WAS ABLE TO FOLLOW-UP WITH DENTIST OFFICE ON (B)(6) 2015, THEY REPORTED THAT AFTER ADVISING THE PATIENT TO DISCONTINUE USING THE KOR DESENSITIZER, THE PATIENT'S SYMPTOMS SUBSIDED AND COMPLETELY DISAPPEARED IN LESS THAN TWO WEEKS. THE PATIENT NO LONGER HAS ANY INTEREST IN CONTINUING WITH ANY TEETH WHITENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495874 KOR TEETH DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE EVOLVE DENTAL TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening