COREGA
Received Apr 24, 2025
Report 1314819-2025-00086 · MDR key 21897882
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 TOOK A PILL BY MISTAKE [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: ON (B)(6) 2025, A SPONTANEOUS CASE WAS REPORTED IN PORTUGAL BY A CONSUMER OR OTHER NON-HEALTH PROFESSIONAL VIA CALL CENTER REPRESENTATIVE (EMAIL). THE REPORT CONCERNS A CONSUMER OF UNKNOWN AGE AND GENDER. ON AN UNKNOWN DATE, THE CONSUMER RECEIVED COREGA (NAPC+POTM+TAED TABLET) TABLET (ALSO REPORTED AS, PILL) AT A DOSE OF 1 DOSAGE FORM (FREQUENCY, ROUTE OF ADMINISTRATION, BATCH/LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED) FOR PRODUCT USED FOR UNKNOWN INDICATION. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING COREGA, THE CONSUMER EXPERIENCED A SERIOUS MEDICALLY SIGNIFICANT EVENT REPORTED AS, "I TOOK A PILL BY MISTAKE" (PT: 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 FOR COREGA WAS UNKNOWN. DECHALLENGE WAS UNKNOWN AND RECHALLENGE WAS NOT APPLICABLE. CAUSALITY FOR THE EVENT WITH RESPECT TO SUSPECT THERAPY WAS NOT REPORTED/NOT ASSESSABLE. 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 TOOK A PILL BY MISTAKE. WHAT TO DO. IS THERE A RISK OF POISONING".
Additional Manufacturer Narrative
VEEVA CASE: (B)(4).