COREGA BIO
Received Jan 22, 2025
Report 1314819-2025-00004 · MDR key 21205646
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 · Female
- 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
SHE SWALLOWED COREGA BIO TABS TABLETS THINKING THEY WERE VITAMINS [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: ON (B)(6) 2025 A SPONTANEOUS CASE WAS REPORTED IN CZECHIA BY A CONSUMER OR OTHER NON-HEALTH PROFESSIONAL VIA CALL CENTRE REPRESENTATIVE (EMAIL). THE REPORT CONCERNS A FEMALE CONSUMER OF UNKNOWN AGE. THE CONSUMER RECEIVED COREGA BIO (NAPC+POTM+TAED TABLET) LOT NUMBER AND EXPIRY DATE NOT REPORTED FOR AN UNKNOWN INDICATION. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING COREGA BIO, THE CONSUMER EXPERIENCED A MEDICALLY SIGNIFICANT "SHE SWALLOWED COREGA BIO TABS TABLETS, THINKING THAT THEY WERE VITAMINS" (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 WERE: FOR COREGA BIO WAS UNKNOWN. DECHALLENGE WAS UNKNOWN AND RECHALLENGE WAS NOT APPLICABLE FOR THE EVENT. THE CAUSALITY ASSESSMENT WAS NOT REPORTED/NOT ASSESSABLE FOR THE EVENT WITH RESPECT TO THE SUSPECT THERAPY. 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'M SORRY TO BOTHER YOU WITH THIS. I WANTED TO ASK. GRANDMA IS ALREADY VERY CONFUSED AT HER AGE AND IT COULD HAVE HAPPENED THAT SHE SWALLOWED COREGA BIO TABS TABLETS, THINKING THAT THEY WERE VITAMINS. SO I WANTED TO ASK YOU VERY MUCH AND ASK IF SHE IS AT RISE OF ANY SERIOUS HEALTH COMPLICATIONS?".
Additional Manufacturer Narrative
VEEVA CASE: (B)(4).