Description of Event or Problem · 0
THIS IS A SPONTANEOUS REPORT RECEIVED VIA SALES REPRESENTATIVE ON (B)(6) 2021 REGARDING A (B)(6) YEAR-OLD FEMALE CONSUMER, WHO DEVELOPED BLISTERS ON LOWER AND UPPER LIP, HAD SENSITIVITY AND REDNESS, SENSATION OF NUMBNESS AND BURNING ON LIPS, TONGUE AND PALATE, TINGLING SENSATION ON LIPS, WOKE UP AT NIGHT, HAD BURNING PAIN IN LIPS, SEVER BURNS ON UPPER AND LOWER LIP, ONLY BEEN ABLE TO EAT BABY FOOD, PALATE AND TONGUE WERE BURNED AND HAD TEARS STREAMING DOWN HER FACE AFTER THE TREATMENT WITH COL OPTIC WHITE PROF KIT IN-OFFICE AT DENTAL OFFICE. THE CONSUMER'S MEDICAL HISTORY INCLUDED GUMS SENSITIVITY AND SEVERAL YEARS AGO, HAD REDNESS AND SENSITIVITY AFTER THE WHITENING TREATMENT. ON (B)(6) 2021, THE CONSUMER WENT TO A DENTIST OFFICE FOR TEETH WHITENING WITH COL OPTIC WHITE PROF KIT IN-OFFICE (LOT NO: 11740BKY6Y). CONSUMER REPORTED THAT IMMEDIATELY AFTER WHITENING PROCEDURE WAS STARTED, SHE STARTED HAVING BURNING PAIN TO HER LIPS AND TOLD THEM AND THEY JUST KEPT APPLYING VASELINE AND CONTINUED WITH THE TREATMENT. CONSUMER TOLD THEM TO STOP MULTIPLE TIMES BECAUSE IT WAS GETTING WORSE AND THEY JUST KEPT TELLING HER IT WAS NORMAL AND KEPT APPLYING MORE VASELINE, USUALLY THE WHITENING PROCEDURE WOULD TAKE 1 HOUR BUT FOR HER THEY TOOK TWO AND A HALF HOURS. SHE MENTIONED THAT TECHNICIAN DID NOT TELL HER OF ANY OF THE RISKS, SHE ASKED HIM TO STOP AND HE DID NOT TELL HER IT WAS ROUTINE, SHE HAD TEARS STREAMING DOWN HER FACE. SHE STATED THAT SINCE THE TREATMENT, SHE HAS CONTINUED TO HAVE BURNING AND TINGLING TO HER LIPS, DEVELOPED BLISTERS ON HER LIPS AND HAD BURNING TO HER TONGUE AND UPPER PALATE. SHE STATED THAT SHE HAD A REACTION TO COL OPTIC WHITE PROF KIT IN-OFFICE AND HAD SENSITIVITY AND REDNESS FROM THAT. ADDITIONALLY CONSUMER HAD SENSATION OF NUMBNESS IN LIP, TONGUE AND PALATE. SHE HAD SEVERS BURNS ON UPPER AND LOWER LIPS AND HER PALATE AND TONGUE WERE BURNED. CONSUMER MENTIONED THAT FOR ONE WEEK SHE HAD ONLY BEEN ABLE TO EAT BABY FOOD AND SHE WAKES AT NIGHT. CONSUMER'S DENTIST TOLD HER TO NOT WORRY AND TOLD HER TO DO THE HOME TREATMENTS FOR 4 TO 5 MORE DAYS WHICH CONSUMER DID NOT DO. SHE CALLED THE DENTIST OFFICE ON (B)(6) 2021, TO REPORT ABOUT ISSUES AND HER DENTIST DID NOT CALL HER BACK FOR TWO DAYS. CONSUMER SPOKE WITH COLLEAGUE OF DENTIST WHO RECOMMENDED SODIUM BICARBONATE RINSE, SINCE CONSUMER IS A DOCTOR AND KNEW THAT WAS A IRRITANT AND DID NOT DO THAT, HER DENTIST CALLED TWO DAYS LATER AND TOLD HER TO DO BLACK TEA RINSE AND SHE DID THAT WHICH WAS HELPFUL. ON (B)(6) 2021, THE TREATMENT WITH COL OPTIC WHITE PROF KIT IN-OFFICE WAS DISCONTINUED. AT THE TIME OF REPORT, BLISTERS ON LIPS HAD RESOLVED, TINGING AND BURNING SENSATION OF LIPS WAS NOT RESOLVED AND OUTCOME OF OTHER EVENTS WERE RESOLVING.