POLIDENT PRO GUARD & RETAINER

Description of Event or Problem

I OCCASIONALLY HAVE THE FEELING OF HYPOXIA AFTER WAKING UP [HYPOXIA] I WAS A LITTLE UNWELL LAST YEAR, USE OF POLIDENT'S CLEANING TABLETS CAUSED ME TO FEEL UNWELL [FEELING UNWELL] I OCCASIONALLY HAVE THE FEELING OF DIZZINESS AFTER WAKING UP [DIZZINESS] MY NAILS STARTED TO TURN PURPLE [NAIL DISCOLORATION] DEVICE USED FOR UNAPPROVED SCHEDULE [DEVICE USED FOR UNAPPROVED SCHEDULE]. CASE DESCRIPTION: ON (B)(6)2025 A SPONTANEOUS CASE WAS REPORTED IN CHINA BY A PATIENT VIA CALL CENTER REPRESENTATIVE (PHONE). THE REPORT CONCERNS AN ADULT FEMALE CONSUMER. THE CONSUMER RECEIVED POLIDENT PRO GUARD AND RETAINER (NAN+NAPC+POTM+TAED TABLET) 2 TIMES A DAY WITH LOT NUMBER D24032201 OF EXPIRY DATE 2026-09-25 FOR INDICATION DENTAL CLEANING. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING POLIDENT PRO GUARD & RETAINER, THE CONSUMER EXPERIENCED A SERIOUS MEDICALLY SIGNIFICANT, OTHER MEDICALLY IMPORTANT CONDITION "I OCCASIONALLY HAVE THE FEELING OF HYPOXIA AFTER WAKING UP" (PREFERRED TERM: HYPOXIA) AND NON-SERIOUS EVENTS "MY NAILS STARTED TO TURN PURPLE" (PREFERRED TERM: NAIL DISCOLORATION), "I WAS A LITTLE UNWELL LAST YEAR, USE OF POLIDENT'S CLEANING TABLETS CAUSED ME TO FEEL UNWELL (PREFERRED TERM: MALAISE), "I OCCASIONALLY HAVE THE FEELING OF DIZZINESS AFTER WAKING UP" ( PREFERRED TERM: DIZZINESS) AND "I HAVE ALWAYS KEPT THE HABIT OF USING IT ONCE IN THE MORNING AND ONCE IN THE EVENING A DAY" (PREFERRED TERM: DEVICE USE ISSUE). THE OUTCOME OF THE EVENTS HYPOXIA, NAIL DISCOLORATION, MALAISE AND DIZZINESS WERE NOT RECOVERED/ NOT RESOLVED/ ONGOING. THE OUTCOME OF THE EVENT DEVICE USE ISSUE WAS UNKNOWN. NO MEDICAL HISTORY WAS REPORTED. NO DRUG HISTORY WAS REPORTED. THE ACTION TAKEN WITH POLIDENT PRO GUARD & RETAINER WAS DRUG WITHDRAWN ON (B)(6)2025. DE-CHALLENGE WAS NO (DRUG WITHDRAWN/REDUCED, OUTCOME WAS ONGOING/ NOT RESOLVED.) AND RECHALLENGE WAS NOT APPLICABLE (NO RECHALLENGE WAS DONE, RECURRENCE IS NOT APPLICABLE) FOR THE EVENTS HYPOXIA, NAIL DISCOLOURATION, MALAISE AND DIZZINESS. DE-CHALLENGE WAS UNKNOWN (ACTION TAKEN WAS UNKNOWN/ OUTCOME WAS UNKNOWN) AND RECHALLENGE WAS NOT APPLICABLE (NO RECHALLENGE WAS DONE, RECURRENCE IS NOT APPLICABLE) FOR THE EVENT DEVICE USE ISSUE. THE CAUSALITY OF THE EVENTS HYPOXIA, NAIL DISCOLOURATION, MALAISE AND DIZZINESS WERE CONSIDERED AS REASONABLE POSSIBILITY AND FOR THE EVENT DEVICE USE ISSUE CAUSALITY WAS CONSIDERED AS NOT REPORTED / NOT ASSESSABLE FOR THE SUSPECT POLIDENT PRO GUARD & RETAINER. THE REPORTER PROVIDED THE FOLLOWING COMMENT: "I AM A LONG-TERM USER OF POLIDENT. I HAVE BEEN USING POLIDENT CLEANING TABLETS FOR THREE TO FOUR YEARS. I STARTED WITH THE GREEN BOX AND THEN THE BLUE BOX FOR TWO YEARS. I FOUND THAT THE BLUE BOX POLIDENT PRO GUARD & RETAINER CLEANSER 60 TABLETS CONTAIN SODIUM NITRITE, WHICH IS HIGHLY TOXIC. I WOULD LIKE TO ASK HOW MANY GRAMS OF ONE BLUE BOX TABLET IS? HOW MANY MILLIGRAMS OF SODIUM NITRITE ARE CONTAINED IN ONE TABLET? I FOUND THAT I WAS A LITTLE UNWELL LAST YEAR. I DON'T KNOW WHEN MY NAILS STARTED TO TURN PURPLE. RECENTLY, I OCCASIONALLY HAVE THE FEELING OF DIZZINESS AND HYPOXIA AFTER WAKING UP. I USUALLY EAT QUITE HEALTHILY. THROUGH MY OWN SCREENING, I NOW SUSPECT THAT THE USE OF POLIDENT'S CLEANING TABLETS CAUSED ME TO FEEL UNWELL. HOWEVER, I HAVEN'T SEEN A DOCTOR YET, SO I PLAN TO ASK YOUR HOTLINE FIRST. I AM IN MY 20S NOW. I HAVE ALWAYS USED THE CLEANING TABLETS ACCORDING TO THE INSTRUCTIONS ON THE PRODUCT LABEL. I SAW ON THE INTERNET THAT IT IS RECOMMENDED TO USE IT 1-2 TIMES A DAY, SO I HAVE ALWAYS KEPT THE HABIT OF USING IT ONCE IN THE MORNING AND ONCE IN THE EVENING A DAY. SOMETIMES I NOTICE THAT THE CLEANING TABLETS ARE NOT COMPLETELY DISSOLVED. I USE ABOUT 250 GRAMS OF WATER TO DISSOLVE THEM EACH TIME. BECAUSE THE STRUCTURE OF BRACES IS UNEVEN, IT IS DIFFICULT TO ENSURE THAT THEY CAN BE COMPLETELY CLEANED EVERY TIME. I AM AFRAID THAT THERE WILL BE RESIDUAL CLEANING TABLETS ON MY BRACES, AND THEN THESE TOXIC SODIUM NITRITES WILL ENTER THE BODY AND CAUSE HARM TO HEALTH. I HAVE USED SEVERAL BOXES CUMULATIVELY. I STARTED USING IT ABOUT 2 YEARS AGO AND STOPPED USING IT 3-4 DAYS AGO. NOW MY BODY HAS NOT RECOVERED. I USED YOUR GREEN BOX AND PURPLE BOX CLEANING TABLETS BEFORE, AND NOW I USE THE BLUE BOX. I ACCEPTED THE FOLLOW-UP VISIT FROM THE SAFETY TEAM. NOW I WANT TO ASK, IS THERE ANY INGREDIENT ADDED TO YOUR BLUE BOX POLIDENT TO NEUTRALIZE THE TOXICITY OF SODIUM NITRITE". THE REPORT IS BEING RESUBMITTED TO CAPTURE CORRECTIONS. THE INFORMATION WAS RECEIVED ON (B)(6)2025 AND IS AS FOLLOWS: DEVICE REPORT TYPE ADDED AS SERIOUS INJURY.

Additional Manufacturer Narrative

VEEVA CASE: (B)(4).

Description of Event or Problem

I OCCASIONALLY HAVE THE FEELING OF HYPOXIA AFTER WAKING UP [HYPOXIA] I WAS A LITTLE UNWELL LAST YEAR, USE OF POLIDENT'S CLEANING TABLETS CAUSED ME TO FEEL UNWELL [FEELING UNWELL] I OCCASIONALLY HAVE THE FEELING OF DIZZINESS AFTER WAKING UP [DIZZINESS] MY NAILS STARTED TO TURN PURPLE [NAIL DISCOLORATION] GASTROINTESTINAL UPSET [GASTROINTESTINAL UPSET] THE DENTIST FOUND THAT THE GUMS ON THE TEETH COVERED BY THE DENTAL RETAINER WERE WHITENING/ GUM TURNED WHITE [GUM DISCOLORATION] AFTER WEARING THE DENTAL RETAINER, THE RESIDUAL PEROXIDE, BAKING SODA AND OTHER INGREDIENTS ON THE RETAINER ATTACHED TO THE TEETH, CORRODING THE GUMS AND THEN TURNING WHITE [GUM EROSION] DEVICE USED FOR UNAPPROVED SCHEDULE [DEVICE USED FOR UNAPPROVED SCHEDULE] WRONG TECHNIQUE IN DEVICE USAGE PROCESS [WRONG TECHNIQUE IN DEVICE USAGE PROCESS]. CASE DESCRIPTION: ON (B)(6) 2025 A SPONTANEOUS CASE WAS REPORTED IN CHINA BY A PATIENT VIA CALL CENTER REPRESENTATIVE (PHONE). ON (B)(6) 2025, NEW INFORMATION WERE RECEIVED FOR THE CASE. THE REPORT CONCERNS AN ADULT FEMALE CONSUMER. THE CONSUMER RECEIVED POLIDENT PRO GUARD AND RETAINER (NAN+NAPC+POTM+TAED TABLET) 2 TIMES A DAY WITH LOT NUMBER D24032201 OF EXPIRY DATE 2026-09-25 FOR INDICATION DENTAL CLEANING. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING POLIDENT PRO GUARD & RETAINER (NAN+NAPC+POTM+TAED TABLET), THE CONSUMER EXPERIENCED A SERIOUS MEDICALLY SIGNIFICANT EVENT"I OCCASIONALLY HAVE THE FEELING OF HYPOXIA AFTER WAKING UP" (PREFERRED TERM: HYPOXIA) AND NON-SERIOUS EVENTS "MY NAILS STARTED TO TURN PURPLE" (PREFERRED TERM: NAIL DISCOLORATION), "I WAS A LITTLE UNWELL LAST YEAR, USE OF POLIDENT'S CLEANING TABLETS CAUSED ME TO FEEL UNWELL (PREFERRED TERM: MALAISE), "I OCCASIONALLY HAVE THE FEELING OF DIZZINESS AFTER WAKING UP" ( PREFERRED TERM: DIZZINESS), "I HAVE ALWAYS KEPT THE HABIT OF USING IT ONCE IN THE MORNING AND ONCE IN THE EVENING A DAY" (PREFERRED TERM: DEVICE USE ISSUE), AFTER A DENTIST'S EXAMINATION, IT WAS FOUND THAT THE GUMS ON THE TEETH COVERED BY THE DENTAL RETAINER HAD TURNED WHITE (PREFERRED TERM: GINGIVAL DISCOLOURATION), AFTER WEARING THE DENTAL RETAINER, THE RESIDUAL PEROXIDE, BAKING SODA AND OTHER INGREDIENTS ON THE RETAINER ATTACHED TO THE TEETH, CORRODING THE GUMS AND THEN TURNING WHITE (PREFERRED TERM: GINGIVAL EROSION), GASTROINTESTINAL UPSET (PREFERRED TERM: ABDOMINAL DISCOMFORT) AND THE DOCTOR SAID THAT THE CONSUMER HAD BEEN USING CLEANING TABLETS TO CLEAN THE DENTAL RETAINER FOR A LONG TIME, BUT DID NOT COMPLETELY CLEAN THE RETAINER AFTER USE WITHOUT KNOWING IT (PREFERRED TERM": WRONG TECHNIQUE IN DEVICE USAGE PROCESS). THE OUTCOME OF THE EVENTS HYPOXIA, NAIL DISCOLORATION, MALAISE, DIZZINESS AND GINGIVAL DISCOLOURATION WERE NOT RECOVERED/ NOT RESOLVED/ ONGOING. THE OUTCOME OF THE EVENT DEVICE USE ISSUE, GINGIVAL EROSION, ABDOMINAL DISCOMFORT AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS WAS UNKNOWN. NO MEDICAL HISTORY WAS REPORTED. NO DRUG HISTORY WAS REPORTED. THE ACTION TAKEN WITH POLIDENT PRO GUARD & RETAINER WAS DRUG WITHDRAWN IN (B)(6) 2025. DE-CHALLENGE WAS NO (DRUG WITHDRAWN/REDUCED, OUTCOME WAS ONGOING/ NOT RESOLVED.) AND RECHALLENGE WAS NOT APPLICABLE (NO RECHALLENGE WAS DONE, RECURRENCE IS NOT APPLICABLE) FOR THE EVENTS HYPOXIA, NAIL DISCOLOURATION, MALAISE, DIZZINESS AND GINGIVAL DISCOLOURATION. DE-CHALLENGE WAS UNKNOWN (ACTION TAKEN WAS UNKNOWN/ OUTCOME WAS UNKNOWN) AND RECHALLENGE WAS NOT APPLICABLE (NO RECHALLENGE WAS DONE, RECURRENCE IS NOT APPLICABLE) FOR THE EVENT DEVICE USE ISSUE, GINGIVAL EROSION, ABDOMINAL DISCOMFORT AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS. THE CAUSALITY OF THE EVENTS HYPOXIA, NAIL DISCOLOURATION, MALAISE, DIZZINESS, GINGIVAL DISCOLOURATION AND GINGIVAL EROSION WERE CONSIDERED AS REASONABLE POSSIBILITY AND FOR THE EVENTS DEVICE USE ISSUE, ABDOMINAL DISCOMFORT AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS CAUSALITY WAS CONSIDERED AS NOT REPORTED / NOT ASSESSABLE FOR THE SUSPECT POLIDENT PRO GUARD & RETAINER. THIS REPORT IS MADE BY HALEON WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. THE REPORTER PROVIDED THE FOLLOWING COMMENT: "I AM A LONG-TERM USER OF POLIDENT. I HAVE BEEN USING POLIDENT CLEANING TABLETS FOR THREE TO FOUR YEARS. I STARTED WITH THE GREEN BOX AND THEN THE BLUE BOX FOR TWO YEARS. I FOUND THAT THE BLUE BOX POLIDENT PRO GUARD & RETAINER CLEANSER 60 TABLETS CONTAIN SODIUM NITRITE, WHICH IS HIGHLY TOXIC. I WOULD LIKE TO ASK HOW MANY GRAMS OF ONE BLUE BOX TABLET IS? HOW MANY MILLIGRAMS OF SODIUM NITRITE ARE CONTAINED IN ONE TABLET? I FOUND THAT I WAS A LITTLE UNWELL LAST YEAR. I DON'T KNOW WHEN MY NAILS STARTED TO TURN PURPLE. RECENTLY, I OCCASIONALLY HAVE THE FEELING OF DIZZINESS AND HYPOXIA AFTER WAKING UP. I USUALLY EAT QUITE HEALTHILY. THROUGH MY OWN SCREENING, I NOW SUSPECT THAT THE USE OF POLIDENT'S CLEANING TABLETS CAUSED ME TO FEEL UNWELL. HOWEVER, I HAVEN'T SEEN A DOCTOR YET, SO I PLAN TO ASK YOUR HOTLINE FIRST. I AM IN MY 20S NOW. I HAVE ALWAYS USED THE CLEANING TABLETS ACCORDING TO THE INSTRUCTIONS ON THE PRODUCT LABEL. I SAW ON THE INTERNET THAT IT IS RECOMMENDED TO USE IT 1-2 TIMES A DAY, SO I HAVE ALWAYS KEPT THE HABIT OF USING IT ONCE IN THE MORNING AND ONCE IN THE EVENING A DAY. SOMETIMES I NOTICE THAT THE CLEANING TABLETS ARE NOT COMPLETELY DISSOLVED. I USE ABOUT 250 GRAMS OF WATER TO DISSOLVE THEM EACH TIME. BECAUSE THE STRUCTURE OF BRACES IS UNEVEN, IT IS DIFFICULT TO ENSURE THAT THEY CAN BE COMPLETELY CLEANED EVERY TIME. I AM AFRAID THAT THERE WILL BE RESIDUAL CLEANING TABLETS ON MY BRACES, AND THEN THESE TOXIC SODIUM NITRITES WILL ENTER THE BODY AND CAUSE HARM TO HEALTH. I HAVE USED SEVERAL BOXES CUMULATIVELY. I STARTED USING IT ABOUT 2 YEARS AGO AND STOPPED USING IT 3-4 DAYS AGO. NOW MY BODY HAS NOT RECOVERED. I USED YOUR GREEN BOX AND PURPLE BOX CLEANING TABLETS BEFORE, AND NOW I USE THE BLUE BOX. I ACCEPTED THE FOLLOW-UP VISIT FROM THE SAFETY TEAM. NOW I WANT TO ASK, IS THERE ANY INGREDIENT ADDED TO YOUR BLUE BOX POLIDENT TO NEUTRALIZE THE TOXICITY OF SODIUM NITRITE". THE REPORT IS BEING RESUBMITTED TO CAPTURE CORRECTIONS. THE INFORMATION WAS RECEIVED ON (B)(6) 2025 AND IS AS FOLLOWS: DEVICE REPORT TYPE ADDED AS SERIOUS INJURY. FOLLOW UP INFORMATION WAS RECEIVED FROM CONSUMER VIA CALL CENTER REPRESENTATIVE (PHONE) ON DATE (B)(6) 2025. THE NEW EVENTS GINGIVAL DISCOLOURATION, GINGIVAL EROSION, ABDOMINAL DISCOMFORT AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS WERE ADDED. THE REPORTER PROVIDED THE FOLLOWING COMMENT: "AFTER A DENTIST'S EXAMINATION, IT WAS FOUND THAT THE GUMS ON THE TEETH COVERED BY THE DENTAL RETAINER HAD TURNED WHITE. THE DOCTOR SAID THAT THE CONSUMER HAD BEEN USING CLEANING TABLETS TO CLEAN THE DENTAL RETAINER FOR A LONG TIME, BUT DID NOT COMPLETELY CLEAN THE RETAINER AFTER USE WITHOUT KNOWING IT. AFTER WEARING THE DENTAL RETAINER, THE RESIDUAL PEROXIDE, BAKING SODA AND OTHER INGREDIENTS ON THE RETAINER ATTACHED TO THE TEETH, CORRODING THE GUMS AND THEN TURNING WHITE. THE CONSUMER REPORTED THAT AFTER STOPPING USING THE CLEANING TABLETS IN THE PAST FEW DAYS, THE BODY AND THE WHITENING OF GUMS HAS IMPROVED. THE CONSUMER SAID THAT SHE WOULD WEAR A DENTAL RETAINER FOR 16-17 HOURS A DAY, BUT WOULD TAKE IT OFF WHEN EATING AND DRINKING COFFEE. THE PATIENT STOPPED USING THE PRODUCT, AND THE ADVERSE REACTION OF "GUMS CHANGED WHITE " WAS NOT RECOVERING SINCE THEN. THE PATIENT IS CURRENTLY TAKING VC TO TREAT THE ADVERSE REACTION. THE PATIENT ALSO EXPERIENCED GASTROINTESTINAL UPSET, BUT IT IS NOT CERTAIN WHETHER IT IS RELATED TO THE PRODUCT. NO OTHER ADVERSE REACTION INFORMATION CAN BE PROVIDED".

Additional Manufacturer Narrative

VEEVA CASE: (B)(4).