BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COL OPTIC WHITE ADVANCED LED WHITENING SYSTEM STARTER KIT

    MDR report key: 11221378 · Received January 25, 2021

    Report

    Report Number
    0002221095-2021-00001
    Event Type
    Injury
    Date Received
    January 25, 2021
    Report Date
    January 5, 2021
    Manufacturer
    COLGATE PALMOLIVE COMPANY
    Product Code
    EFW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT RECEIVED FROM A FEMALE CONSUMER (AGE RANGE 19-24) ON 05JAN2021, WHO SUFFERED EXTREME BURNS ALONG LOWER GUM LINE, COULD NOT EAT, COULD NOT EVEN TALK BECAUSE OF THE EXTREME PAIN, DESTROYED MOUTH AND LITERALLY BURNT GUMS OFF OF TEETH AFTER USING COL OPTIC WHITE ADVANCED LED WHITENING SYSTEM STARTER KIT. THERE WAS NO RELEVANT MEDICAL HISTORY PROVIDED. ON AN UNKNOWN DATE, CONSUMER STARTED USING COL OPTIC WHITE ADVANCED LED WHITENING SYSTEM STARTER KIT. CONSUMER REPORTED SHE USED PRODUCT FOLLOWING THE PACKAGE INSTRUCTIONS "TO A T". CONSUMER REPORTED SHE USED COL OPTIC WHITE ADVANCED LED WHITENING SYSTEM STARTER KIT TWO DAYS IN A ROW AND "SUFFERED EXTREME BURNS ALONG MY LOWER GUM LINE". CONSUMER REPORTED SHE COULD NOT EAT, BRUSH TEETH OR EVEN TALK BECAUSE OF THE EXTREME PAIN CAUSED BY THE BURNS. CONSUMER REPORTED CONCERN OF BEING AT "EXTREME RISK FOR INFECTION" DUE TO THE EVENTS AND WILL NEED TO SEE A DENTIST TO GET THE BURNS TREATED. CONSUMER STATED THE "PRODUCT DESTROYED MY MOUTH AND LITERALLY BURNT MY GUMS OFF OF MY TEETH". CONSUMER REPORTED SHE HAD NOT EXPERIENCED THIS ISSUE WITH OTHER UNSPECIFIED WHITENING PRODUCTS USED IN THE PAST. ACTION TAKEN WITH COL OPTIC WHITE ADVANCED LED WHITENING SYSTEM STARTER KIT WAS UNKNOWN. AT THE TIME OF REPORT, OUTCOME OF THE EVENTS WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124837 COL OPTIC WHITE ADVANCED LED WHITENING SYSTEM STARTER KIT COL OPTIC WHITE ADVANCED LED WHITENING SYSTEM STARTER KIT EFW COLGATE PALMOLIVE COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other