COREGA BIO-ACTIVE OXYGEN
Received Mar 11, 2025
Report 1314819-2025-00048 · MDR key 21570511
Device
Generic name
Denture Cleanser
Lot number
HR3A
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
31 YR · Male
- Pain
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Pain
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
VEEVA CASE: (B)(4).
Description of Event or Problem
BECAUSE I WAS GOING TO TAKE A PILL AND I CONFUSED IT WITH A GLASS OF WATER.,SO. IT WAS AN ACCIDENT [ACCIDENTAL DEVICE INGESTION], MY STOMACH STILL HURTS [STOMACH PAIN]. CASE DESCRIPTION: ON (B)(6) 2025 A SPONTANEOUS CASE WAS REPORTED IN SPAIN BY A PATIENT VIA CALL CENTER REPRESENTATIVE (PHONE). THE REPORT CONCERNS A 31-YEAR-OLD, ADULT MALE CONSUMER. THE CONSUMER RECEIVED COREGA BIO-ACTIVE OXYGEN (NAPC+POTM+TAED TABLET) LOT NUMBER HR3A, EXPIRY DATE 2025-09-30 FOR INDICATION PRODUCT USED FOR UNKNOWN INDICATION. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING COREGA BIO-ACTIVE OXYGEN, THE CONSUMER EXPERIENCED A SERIOUS MEDICALLY SIGNIFICANT CONDITION, BECAUSE I WAS GOING TO TAKE A PILL AND I CONFUSED IT WITH A GLASS OF WATER, SO. IT WAS AN ACCIDENT (PREFERRED TERM: ACCIDENTAL DEVICE INGESTION). ON AN UNKNOWN DATE, THE CONSUMER EXPERIENCED A NON-SERIOUS EVENT, MY STOMACH STILL HURTS, (PREFERRED TERM: ABDOMINAL PAIN UPPER). THE OUTCOME OF THE EVENT ACCIDENTAL DEVICE INGESTION WAS UNKNOWN. THE OUTCOME OF THE EVENT ABDOMINAL PAIN UPPER WAS NOT RECOVERED/NOT RESOLVED/ONGOING. NO MEDICAL HISTORY WAS REPORTED. NO DRUG HISTORY WAS REPORTED. THE ACTION TAKEN WITH COREGA BIO-ACTIVE OXYGEN WAS UNKNOWN. DECHALLENGE WAS UNKNOWN AND RECHALLENGE WAS NOT APPLICABLE. CAUSALITY OF THE EVENT ACCIDENTAL DEVICE INGESTION AND ABDOMINAL PAIN UPPER WERE NOT REPORTED/NOT ASSESSABLE TO THE SUSPECT COREGA BIO-ACTIVE OXYGEN. 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: "YES, THE PRODUCT- THE PRODUCT I INGESTED HAS BEEN FROM BECAUSE I WAS GOING TO TAKE A PILL AND I CONFUSED IT WITH A GLASS OF WATER. YES, IT'S BEEN 12-15 HOURS AND MY STOMACH STILL HURTS, SO. IT WAS AN ACCIDENT. OF COURSE, AS THE BOX SAYS IN CASE OF INGESTION CALL AN INFORMATION CENTER.I NEED TO KNOW: - INGREDIENTS IN THIS PRODUCT, - POSSIBLE ADVERSE EFFECTS. THE SUSPECT PRODUCT WAS REPORTED AS COREGA BIO-ACTIVE OXYGEN EFFERVESCENT TABLETS 108CT".