BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KÖR DESENSITIZER

    MDR report key: 6071543 · Received November 1, 2016

    Report

    Report Number
    3010407924-2016-00027
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 30, 2016
    Manufacturer
    EVOLVE DENTAL TECHNOLOGIES, INC.
    Product Code
    KLE
    PMA / PMN Number
    K953405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    PROBABLE ALLERGIC REACTION TO THE HEMA IN THE DESENSITIZER.

    Description of Event or Problem · 1

    DENTAL OFFICE REPORTED THAT THE PATIENT WHITENED ONE NIGHT, AND THE NEXT DAY (ON (B)(6) 2016) PATIENT CALLED THE OFFICE TO REPORT THAT SHE HAD SWOLLEN LIPS. THE PATIENT SAW HER DENTIST ON MONDAY ((B)(6) 2016) AND SAID SHE WOULD NOT ATTEMPT WHITENING AGAIN. DENTAL OFFICE ADVISED PATIENT TO DISCONTINUE USING THE DESENSITIZER PERMANENTLY. FOLLOWED-UP WITH OFFICE, WHO REPORTED PATIENT'S SWELLING AND DISCOMFORT HAD SUBSIDED AFTER 6 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719846 KÖR DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE EVOLVE DENTAL TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening