POLIDENT
Received Apr 24, 2025
Report 1314819-2025-00085 · MDR key 21897837
Device
Generic name
Denture Cleanser
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
VEEVA CASE: (B)(4).
Description of Event or Problem
I DRANK JUST A BIT OF THE SOLUTION [ACCIDENTAL DEVICE INGESTION] CASE DESCRIPTION: ON (B)(6) 2025 A SPONTANEOUS CASE WAS REPORTED IN UNITED STATES OF AMERICA BY A CONSUMER OR OTHER NON-HEALTH PROFESSIONAL VIA CALL CENTRE REPRESENTATIVE (PHONE). THE REPORT CONCERNS A CONSUMER WITH UNSPECIFIED GENDER AND AGE GROUP. THE CONSUMER RECEIVED POLIDENT (NAPC+POTM+TAED TABLET) WITH UNKNOWN LOT NUMBER FOR UNKNOWN INDICATION. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING POLIDENT, THE CONSUMER EXPERIENCED A SERIOUS MEDICALLY SIGNIFICANT, OTHER IMPORTANT CONDITION EVENT I DRANK JUST A BIT OF THE SOLUTION (PREFERRED TERM: ACCIDENTAL DEVICE INGESTION). THE OUTCOME OF THE EVENT ACCIDENTAL DEVICE INGESTION WAS UNKNOWN. NO MEDICAL HISTORY WAS REPORTED. NO DRUG HISTORY WAS REPORTED. THE ACTION TAKEN WITH POLIDENT WAS UNKNOWN. DECHALLENGE WAS UNKNOWN AND RECHALLENGE WAS NOT APPLICABLE FOR THE EVENT ACCIDENTAL DEVICE INGESTION. THE CAUSALITY FOR THE EVENT ACCIDENTAL DEVICE INGESTION WAS ASSESSED AS NOT REPORTED / NOT ASSESSABLE FOR THE SUSPECT POLIDENT. 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 WAS REACHING FOR MY GLASS OF WATER AND I DRANK JUST A BIT OF THE SOLUTION. I GOT POISON CONTROL ON THE LINE I'LL CALL YOU BACK". CASE PRODUCT: POLIDENT DEVICE MFR NUMBER: 1314819-2025-00085.