POLIDENT
Received May 7, 2025
Report 1314819-2025-00091 · MDR key 21974076
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
Description of Event or Problem
I ACCIDENTALLY SWALLOWED ONE OF YOUR PRODUCTS POLIDENT 1/4TH OF THE TABLET. [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 (PHONE) CALL CENTER REPRESENTATIVE. THE REPORT CONCERNS A CONSUMER OF UNKNOWN DEMOGRAPHICS. THE CONSUMER RECEIVED POLIDENT (NAN+NAPC+POTM+TAED TABLET) FOR INDICATION DRUG USE FOR UNKNOWN INDICATION. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING POLIDENT, THE CONSUMER EXPERIENCED A MEDICALLY SIGNIFICANT EVENT OF I ACCIDENTALLY SWALLOWED ONE OF YOUR PRODUCTS POLIDENT 1/4TH OF THE TABLET (PREFERRED TERM: ACCIDENTAL DEVICE INGESTION). THE OUTCOME OF THE EVENT I ACCIDENTALLY SWALLOWED ONE OF YOUR PRODUCTS POLIDENT 1/4TH OF THE TABLET WAS UNKNOWN. NO MEDICAL HISTORY AND DRUG HISTORY WAS REPORTED. THIS REPORT IS MADE BY HALEON WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. THE ACTION TAKEN FOR POLIDENT WAS UNKNOWN. DECHALLENGE WAS UNKNOWN AND RECHALLENGE WAS NOT APPLICABLE. CAUSALITY WAS NOT REPORTED/NOT ASSESSABLE FOR THE EVENT WITH RESPECT TO POLIDENT. CASE PRODUCT: POLIDENT DEVICE MFR NUMBER: THE REPORTER PROVIDED THE FOLLOWING COMMENT: "I ACCIDENTALLY SWALLOWED ONE OF YOUR PRODUCTS POLIDENT1/4TH OF THE TABLET." THE REPORT IS BEING RESUBMITTED TO CAPTURE CORRECTIONS. THIS CASE IS REOPENED ON 2025-05-05 TO CAPTURE CORRECTIONS FOR INFORMATION RECEIVED ON 2025-04-30 AND IS AS FOLLOWS: DEVICE REPORT TYPE ADDED AS SERIOUS INJURY.
Additional Manufacturer Narrative
VEEVA CASE: (B)(4).