BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KÖR DESENSITIZER

    MDR report key: 6153776 · Received December 8, 2016

    Report

    Report Number
    3010407924-2016-00029
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    November 5, 2016
    Report Date
    November 9, 2016
    Manufacturer
    EVOLVE DENTAL TECHNOLOGIES, INC.
    Product Code
    KLE
    PMA / PMN Number
    K953405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PROBABLE ALLERGIC REACTION TO THE HEMA IN THE DESENSITIZER.

    Description of Event or Problem · 1

    DENTIST REPORTED THAT HIS PATIENT CALLED AND INFORMED HIM SHE'S HAD SWOLLEN LIPS FOR 5 DAYS. DENTIST STATED THAT THE PATIENT HAS BEEN WHITENING SINCE (B)(6) 2016, AND HER LIPS DID NOT SWELL UP UNTIL (B)(6) 2016. HE ALREADY ADVISED THE PATIENT TO DISCONTINUE ALL WHITENING AND DESENSITIZING INDEFINITELY. FOLLOWED UP WITH DENTIST ON (B)(6) 2016, DENTIST STATED THAT THE PATIENT HAD COMPLETELY RETURNED TO NORMAL BY (B)(6) 2016 (ABOUT THREE WEEKS AFTER THE INITIAL REACTION). THE PATIENT DID NOT SEE HER GENERAL PRACTITIONER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806296 KÖR DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE EVOLVE DENTAL TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening