BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOR TOOTH DESENSITIZER

    MDR report key: 5074886 · Received September 10, 2015

    Report

    Report Number
    3010407924-2015-00016
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    August 22, 2015
    Report Date
    August 24, 2015
    Manufacturer
    EVOLVE DENTAL TECHNOLOGIES INC.
    Product Code
    KLE
    PMA / PMN Number
    K953405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 REPORTING THAT THE PATIENT WHITENED FOR THE FIRST NIGHT ON FRIDAY, (B)(6) 2015. WHEN SHE WOKE UP ON SATURDAY, HER LIPS WERE DRY AND CRACKED AND AS THE DAY PROGRESSED, HER LIPS BECAME SWOLLEN AND PUFFY, AND SHE DEVELOPED BLISTERING ON THE OUTSIDE OF THER MOUTH. WE INFORMED OFFICE ABOUT THE HEMA PRODUCT IN THE DESENSITIZER, AND ADVISED TO CALL THE PATIENT ASAP AND ADVISE HER TO DISCONTINUE USE OF THE KOR DESENSITIZER INDEFINITELY, AND THAT THE PATIENT SHOULD EE HER GENERAL PRACTITIONER FOR ANY HELP REGARDING HER SYMPTOMS; THE PATIENT WAS IN THE CHAIR WHEN THEY CONTACTED EVOLVE DENTAL ON THE MORNING OF (B)(6) 2015, AND STILL HAD SOME SWELLING AND BLISTERING. FOLLOWED UP W/DENTIST'S OFFICE ON (B)(6) 2015. AFTER THE PATIENT VISITED HER GENERAL PRACTITIONER TO HELP SPEED UP HER RECOVERY, THE PATIENT'S SYMPTOMS HAVE SUBSIDED, AND SHE HAS RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599463 KOR TOOTH DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE EVOLVE DENTAL TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening