COREGA 3 IN 1

Additional Manufacturer Narrative

VEEVA CASE: (B)(4).

Description of Event or Problem

IT STAYED IN MY THROAT [FOREIGN BODY IN THROAT]. PRODUCT DOES NOT HOLD [DEVICE ADHESION INSUFFICIENT]. CASE DESCRIPTION: ON 2025-03-18 A SPONTANEOUS CASE WAS REPORTED IN BRAZIL BY A PATIENT. THE REPORT CONCERNS A FEMALE CONSUMER. THE CONSUMER RECEIVED COREGA 3 IN 1 (CARNA+POLMA POWDER)LOT NUMBER 5B7A FOR INDICATION LOOSE DENTURES. EXPIRY DATE OF THE PRODUCT WAS 2025-04-30 THIS CASE IS ASSOCIATED WITH PRODUCT COMPLAINT. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING COREGA 3 IN 1, THE CONSUMER EXPERIENCED A MEDICALLY SIGNIFICANT IT STAYED IN MY THROAT (PREFERRED TERM: FOREIGN BODY IN THROAT). THE OUTCOME OF THE EVENT IT STAYED IN MY THROAT WAS RECOVERED/RESOLVED. ON AN UNKNOWN DATE, THE CONSUMER EXPERIENCED A NON SERIOUS PRODUCT DOES NOT HOLD, (PREFERRED TERM: DEVICE ADHESION ISSUE). THE OUTCOME OF THE EVENT PRODUCT DOES NOT HOLD WAS UNKNOWN. NO MEDICAL HISTORY WAS REPORTED. NO DRUG HISTORY WAS REPORTED. THE ACTION TAKEN WERE: FOR COREGA 3 IN 1 WAS UNKNOWN. DECHALLENGE WAS UNKNOWN AND RECHALLENGE WAS NOT APPLICABLE. THE CAUSALITY OF THE EVENT FOREIGN BODY IN THROAT WAS REASONABLE POSSIBILITY AND FOR DEVICE ADHESION ISSUE IT 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: "THE PROBLEM IS THE CORE THAT I BOUGHT FOR COREGA POST-FIXATION FIXATIVE, IT MADE MY PROSTHESIS FALL OUT AND ALMOST SWALLOWED IT, THEN I PUT IT ON MY PROSTHESIS AND ALMOST SWALLOWED IT BECAUSE IT DIDN'T FIX, IN MY THROAT, IT STAYED IN MY THROAT. SEVERAL TIMES WITH ME WITH CREAM TOO. I JUST WANT MY MONEY BACK".. FOLLOW UP INFORMATION WAS RECEIVED FROM QUALITY ASSURANCE (QA) DEPARTMENT ON 18MAR2025 REGARDING COMPLAINT (B)(4) FOR SUSPECT DRUG WITH LOT NUMBER 5B7A INVESTIGATION EVALUATION: ALL COREGA POWDER PRODUCTS ARE SPECIALLY FORMULATED TO FORM A TIGHT SEAL AND PROVIDE A FIRM HOLD FOR DENTURES. THEIR ACTIVE ADHESIVES ARE POLYOX (SUPER COREGA AND SUPER COREGA NO FLAVOUR) AND GANTREZ SALT (ULTRA COREGA AND ULTRA COREGA NO FLAVOUR). ALSO, IN COREGA POWDER FORMULATIONS, CMC (CARBOXYMETHYLCELLULOSE) ACTS AS A VISCOSITY MODIFIER/THICKENER. WHEN CMC INTERACTS WITH SALIVA IN THE MOUTH, IT PROVIDES HIGH VISCOSITY TO THE FORMULATION PROMOTING THE ADHESIVE STRENGTH. AFTER PERFORMED TESTS WITH COREGA POWDER, IT HAS BEEN SHOWN TO BE EFFECTIVE IN PROVIDING 12 HOURS HOLD. ALTHOUGH, COMPLAINTS FOR "PRODUCT DOES NOT HOLD" HAVE BEEN RECEIVED OVER THE LAST YEARS, THIS KIND OF COMPLAINT CAN BE RELATED TO DIFFERENCES IN FIXING OF DENTURES OF INDIVIDUAL CUSTOMERS. WHEN CUSTOMERS USE DENTURES IN CONDITION OF POOR FIXING, ESPECIALLY IF THERE IS SOME GAP BETWEEN DENTURE AND THE GUM, THE PRODUCT CANNOT REACH EXPECTED ADHESIVENESS DURING THE LATEST 2 YEARS (FROM NOVEMBER, 2021 TO NOVEMBER, 2023), A TOTAL OF 310 COMPLAINTS REGARDING "PRODUCT DOES NOT HOLD" FOR COREGA POWDER® HAVE BEEN RECEIVED, AS SHOWN IN CHART 1. ON JANUARY 03RD, 2018, VERSION 01 OF THIS CIM WAS IMPLEMENTED AND ALL COMPLAINTS RELATED TO THIS REASON CODE WERE CLOSED WITH THIS DOCUMENT. HOWEVER, ALL COMPLAINTS RECEIVED BEFORE VERSION 01 IMPLEMENTATION WERE EVALUATED AND INVESTIGATED BY THE CHEMICAL LAB AND QUALITY ASSURANCE AREAS. ALSO, COMPLAINED SAMPLES RECEIVED WERE TESTED FOR ACTIVE INGREDIENT ASSAY. ALL COMPLAINTS WERE CLASSIFIED AS UNSUBSTANTIATED. ALL BATCHES DOCUMENTATION WERE REVIEWED, ALSO, AND THERE WAS NO RECORD OF ISSUE THAT MIGHT HAVE LED TO THIS KIND OF COMPLAINT DURING CHEMICAL ANALYSIS FOR BATCH RELEASE. ACTIVE INGREDIENT CONTENT WAS WITHIN SPECIFICATION AND THE PRODUCT HAS BEEN MANUFACTURED WITHIN ALL REQUIRED QUALITY STANDARDS. ALSO, AFTER CIM IMPLEMENTATION UNTIL NOW, CRITICAL COMPLAINTS RELATED TO PRODUCT DOES NOT HOLD WERE INVESTIGATION. ALL BATCH DOCUMENTATIONS WERE REVIEWED AND THERE WAS NOT FOUND ANY ISSUE. AS WITH ANY PRODUCT, IT IS EXPECTED THAT THE CONSUMERS MAY HAVE DIFFERENT EXPERIENCES BASED ON VARIOUS INDIVIDUAL FACTORS, LIKE THE FIT OF THE DENTURE AND THE ORAL ANATOMY OF THE DENTURE WEARER, WHICH MAY DETERMINE THE PERFORMANCE OF THE DENTURE. BASED ON RELEASE TESTING, QUALITY CONTROLS IN PLACE, STABILITY TESTING AND PRIOR COMPLAINTS INVESTIGATIONS OF COREGA POWDER, THIS TYPE OF COMPLAINT DOES NOT NEED ADDITIONAL TESTING AND CAN BE HANDLED BY STANDARD RESPONSE (CIM). ALSO, THIS KIND OF COMPLAINT IS NOT RELATED TO QUALITY ISSUE AND DOES NOT AFFECT THE SAFETY OR EFFICIENCY OF THE PRODUCT. RESPONSE TO CONSUMER: WHILE USING THE PRODUCT, IT IS EXPECTED THAT THE CONSUMER COULD HAVE DIFFERENT EXPERIENCES BASED ON VARIOUS INDIVIDUAL FACTORS, SUCH AS THE FIT OF THE DENTURE AND THE ORAL ANATOMY OF THE DENTURE WEARER, WHICH WILL DETERMINE THE PERFORMANCE OF THE DENTURE ADHESIVE. TO OBTAIN AN OPTIMUM ADHESION IT IS VERY IMPORTANT TO FOLLOW PRODUCT DIRECTIONS DESCRIBED ON THE PACKAGING. THE PRODUCT REPORTED HAS BEEN FOUND TO BE WITHIN SPECIFICATIONS AND MEETS ALL QUALITY REQUIREMENTS. ALL DOCUMENTATION ASSOCIATED WITH THE MANUFACTURING, PACKAGING, AND TESTING OF PRODUCT IS REVIEWED BY THE SITE QUALITY DEPARTMENT TO VERIFY COMPLIANCE PRIOR TO PRODUCT RELEASE AND COMMERCIALIZATION CONCLUSION: UNSUBSTANTIATED THE PQC NUMBER WAS REPORTED AS (B)(4). INITIAL AND FOLLOW UP WERE PROCESSED TOGETHER.