Description of Event or Problem · 1
THIS CASE WAS RECEIVED BY COLGATE PALMOLIVE COMPANY FROM A CONSUMER WHO REPORTED REGARDING ONE OF OUR COSMETIC PRODUCT (COL OPTIC WHITE ADVANCED LED WHITENING SYSTEM STARTER KIT). WE HAVE RECORDED THIS CASE INTO OUR SAFETY SYSTEM WITH ID "US-COLGATE PALMOLIVE COMPANY-(B)(4)". WE ARE USING MEDWATCH PORTAL TO SUBMIT THIS COSMETIC REPORT TO USFDA. THIS IS A SPONTANEOUS REPORT RECEIVED FROM A FEMALE CONSUMER (AGE RANGE 19-24) ON (B)(6) 2021, 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.