BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOR DESENSITIZER

    MDR report key: 5074888 · Received September 10, 2015

    Report

    Report Number
    3010407924-2015-00017
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 26, 2015
    Manufacturer
    EVOLVE DENTAL TECHNOLOGIES INC.
    Product Code
    KLE
    PMA / PMN Number
    K953405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REPORTED THAT A PATIENT STARTED TO DEVELOP SWELLING OF THE LIPS AFTER THE 3RD NIGHT OF WHITENING. WE INSTRUCTED THE DR. TO INFORM HIS PATIENT TO STOP ALL WHITENING UNTIL ALL SYMPTOMS SUBSIDE. THEN THE PT. MAY BEGIN TO WHITEN EXCEPT THEY WOULD NO LONGER USE THE DESENSITIZER AS THE HEMA IS LIKELY TO HAVE CAUSED THE PT TO HAVE AN ALLERGIC REACTION. TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599255 KOR DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE EVOLVE DENTAL TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening