POLIGRIP DENTURE ADHESIVE

Additional Manufacturer Narrative

VEEVA CASE: (B)(4).

Description of Event or Problem

IT'S LIKE A BIG GLOB IN MY THROAT [MEDICATION STUCK IN THROAT]. NIGHT IF I SWALLOW ANY OF THAT, IT'S LIKE A BIG GLOB IN MY THROAT AND I CAN'T BREATHE [ACCIDENTAL DEVICE INGESTION]. I CAN'T BREATHE [BREATHING DIFFICULT]. I HAVE TO PUT TOO MUCH OF THE PRODUCT ON MY DENTURES, OTHERWISE IT DOESN'T HOLD WELL. IF I PUT TOO LITTLE IT HOLDS UNTIL THE AFTERNOON AND THEN MY DENTURES BECOME LOOSE/. I HAVE TO USE DRY PAPER TOWEL TO REMOVE THE ADHESIVE AFTERWARDS [WRONG TECHNIQUE IN DEVICE USAGE PROCESS]. I HAVE ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE [DEVICE DIFFICULT TO REMOVE]. I HAVE ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE FROM MY GUMS. I AM NOT ABLE TO DO SO [PRODUCT COMPLAINT]. CASE DESCRIPTION: ON 2024-06-27 A SPONTANEOUS CASE WAS REPORTED IN UNITED STATES OF AMERICA BY A PATIENT VIA CALL CENTER REPRESENTATIVE (PHONE). ON 2024-07-05 NEW INFORMATION WAS RECEIVED FOR THIS CASE. THE REPORT CONCERNS A CONSUMER. THE CONSUMER RECEIVED POLIGRIP DENTURE ADHESIVE (CARNA+POLMA POWDER) LOT NUMBER RR36W AND EXPIRY DATE 2025-10-31 FOR INDICATION DENTURE WEARER. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING POLIGRIP DENTURE ADHESIVE, THE CONSUMER EXPERIENCED A MEDICALLY SIGNIFICANT FOREIGN BODY IN THROAT (IT'S LIKE A BIG GLOB IN MY THROAT) AND A MEDICALLY IMPORTANT CONDITION (ACCIDENTAL DEVICE INGESTION) NIGHT IF I SWALLOW ANY OF THAT, IT'S LIKE A BIG GLOB IN MY THROAT AND I CAN'T BREATHE. ON AN UNKNOWN DATE, THE CONSUMER EXPERIENCED A NON SERIOUS (DEVICE DIFFICULT TO USE) I HAVE ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE, (WRONG TECHNIQUE IN DEVICE USAGE PROCESS) I HAVE TO PUT TOO MUCH OF THE PRODUCT ON MY DENTURES, OTHERWISE IT DOESN'T HOLD WELL. IF I PUT TOO LITTLE IT HOLDS UNTIL THE AFTERNOON AND THEN MY DENTURES BECOME LOOSE/. I HAVE TO USE DRY PAPER TOWEL TO REMOVE THE ADHESIVE AFTERWARDS, (DYSPNOEA) I CAN'T BREATHE, AND (PRODUCT COMPLAINT) I HAVE ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE FROM MY GUMS. I AM NOT ABLE TO DO SO. THE OUTCOME OF THE EVENT FOREIGN BODY IN THROAT (IT'S LIKE A BIG GLOB IN MY THROAT), (ACCIDENTAL DEVICE INGESTION) NIGHT IF I SWALLOW ANY OF THAT, IT'S LIKE A BIG GLOB IN MY THROAT AND I CAN'T BREATHE, (DEVICE DIFFICULT TO USE) I HAVE ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE, (WRONG TECHNIQUE IN DEVICE USAGE PROCESS) I HAVE TO PUT TOO MUCH OF THE PRODUCT ON MY DENTURES, OTHERWISE IT DOESN'T HOLD WELL. IF I PUT TOO LITTLE IT HOLDS UNTIL THE AFTERNOON AND THEN MY DENTURES BECOME LOOSE/. I HAVE TO USE DRY PAPER TOWEL TO REMOVE THE ADHESIVE AFTERWARDS, (DYSPNOEA) I CAN'T BREATHE, AND (PRODUCT COMPLAINT) I HAVE ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE FROM MY GUMS. I AM NOT ABLE TO DO SO WAS UNKNOWN. NO MEDICAL HISTORY WAS REPORTED. NO DRUG HISTORY WAS REPORTED. THE ACTION TAKEN WERE: FOR POLIGRIP DENTURE ADHESIVE WAS UNKNOWN WITH DECHALLENGE AS UNKNOWN AND RECHALLENGE AS NOT APPLICABLE. CAUSALITY ASSESSMENT 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 CASE IS ASSOCIATED WITH PRODUCT COMPLAINT. THE REPORTER PROVIDED THE FOLLOWING COMMENT: "I USE THIS POLIGRIP DENTURE ADHESIVE POWDER 1.6OZ AND THE POLIGRIP DENTURE ADHESIVE STRIPS 40CT. I HAVE USED BOTH PRODUCTS IN THE PAST AS WELL AND I HAVE ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE FROM MY GUMS. I AM NOT ABLE TO DO SO. I AM SURE I AM NOT DOING SOMETHING RIGHT BECAUSE I HAVE TO PUT TOO MUCH OF THE PRODUCT ON MY DENTURES, OTHERWISE IT DOESN'T HOLD WELL. IF I PUT TOO LITTLE IT HOLDS UNTIL THE AFTERNOON AND THEN MY DENTURES BECOME LOOSE, AND IT'S ALWAYS BEEN LIKE THAT. THIS IS WHY I ALWAYS PUT WAY TOO MUCH AND I CAN'T GET IT ALL OUT. DURING THE NIGHT IF I SWALLOW ANY OF THAT, IT'S LIKE A BIG GLOB IN MY THROAT AND I CAN'T BREATHE. I HAVE TO USE DRY PAPER TOWEL TO REMOVE THE ADHESIVE AFTERWARDS. I AM CALLING TO ASK IF YOU HAVE ANY TRICKS THAT WILL HELP ME REMOVE THE ADHESIVE EASIER?". FOLLOW UP INFORMATION WAS RECEIVED ON 2024-06-27 FROM QUALITY ASSURANCE (QA) DEPARTMENT REGARDING PRODUCT QUALITY COMPLAINT WITH CASE NUMBER (B)(4) FOR LOT NUMBER RR36W. INVESTIGATION EVALUATION: NO SAMPLE WAS RETURNED FOR THIS COMPLAINT AND THE LOT/BATCH DETAILS WERE NOT RECEIVED SO A FULL INVESTIGATION CANNOT BE COMPLETED. AS THIS INFORMATION IS NOT AVAILABLE THE COMPLAINT CANNOT BE SUBSTANTIATED AND WILL BE CLOSED AS INCONCLUSIVE. IF THE CONSUMER CONTACTS US WITH ADDITIONAL INFORMATION OR IF THE COMPLAINT SAMPLE IS RECEIVED, THE COMPLAINT ISSUE WILL BE REOPENED AND FURTHER EVALUATED. RESPONSE TO CONSUMER: NO SAMPLE WAS RETURNED FOR THIS COMPLAINT, ALSO BATCH DETAILS WERE NOT RECEIVED SO A FULL INVESTIGATION COULD NOT BE COMPLETED. AS THIS INFORMATION IS NOT AVAILABLE THE COMPLAINT CANNOT BE SUBSTANTIATED. ALL OF THE DOCUMENTATION PERTINENT TO A SPECIFIC LOT OF FINISHED PRODUCT IS CONTAINED IN A 'BATCH ENVELOPE'. PRIOR TO THE DISPOSITION OF THE PRODUCT, THE CONTENTS OF EACH BATCH ENVELOPE IS REVIEWED & APPROVED BY THE SITE QUALITY DEPARTMENT TO VERIFY THAT THERE WERE NO SIGNIFICANT QUALITY ISSUES RECORDED DURING MANUFACTURING, PACKAGING OR TESTING. THIS REVIEW ALSO VERIFIES THAT ALL TEST RESULTS MEET SPECIFICATION REQUIREMENTS. THE INVESTIGATION REPORTS CONCLUDED THAT, COMPLAINT STANDS INCONCLUSIVE. THE PQC NUMBER WAS REPORTED AS (B)(4). ON 2024-07-05, THE FOLLOWING UPDATES HAVE BEEN PROVIDED - INFORMATION RECEIVED FROM QUALITY ASSURANCE (QA) DEPARTMENT REGARDING PRODUCT QUALITY COMPLAINT WITH CASE NUMBER (B)(4) FOR UNKNOWN LOT NUMBER. INVESTIGATION EVALUATION: NO SAMPLE WAS RETURNED FOR THIS COMPLAINT AND THE LOT/BATCH DETAILS WERE NOT RECEIVED SO A FULL INVESTIGATION CANNOT BE COMPLETED. AS THIS INFORMATION IS NOT AVAILABLE THE COMPLAINT CANNOT BE SUBSTANTIATED AND WILL BE CLOSED AS INCONCLUSIVE. IF THE CONSUMER CONTACTS US WITH ADDITIONAL INFORMATION OR IF THE COMPLAINT SAMPLE IS RECEIVED, THE COMPLAINT ISSUE WILL BE REOPENED AND FURTHER EVALUATED. RESPONSE TO CONSUMER (IF APPLICABLE): NO SAMPLE WAS RETURNED FOR THIS COMPLAINT, ALSO BATCH DETAILS WERE NOT RECEIVED SO A FULL INVESTIGATION COULD NOT BE COMPLETED. AS THIS INFORMATION IS NOT AVAILABLE THE COMPLAINT CANNOT BE SUBSTANTIATED. ALL OF THE DOCUMENTATION PERTINENT TO A SPECIFIC LOT OF FINISHED PRODUCT IS CONTAINED IN A [?]BATCH ENVELOPE'. PRIOR TO THE DISPOSITION OF THE PRODUCT, THE CONTENTS OF EACH BATCH ENVELOPE IS REVIEWED AND APPROVED BY THE SITE QUALITY DEPARTMENT TO VERIFY THAT THERE WERE NO SIGNIFICANT QUALITY ISSUES RECORDED DURING MANUFACTURING, PACKAGING OR TESTING. THIS REVIEW ALSO VERIFIES THAT ALL TEST RESULTS MEET SPECIFICATION REQUIREMENTS. THE INVESTIGATION REPORTS CONCLUDED THAT, COMPLAINT STANDS COMPLAINT INCONCLUSIVE. THE PQC NUMBER WAS REPORTED AS (B)(4). THIS CASE IS 1 OF 2 FOR THE SAME PATIENT. THE CASES (B)(4) ARE CREATED. PLEASE SEE THE CASE (B)(4) (WITH THE SUSPECT PRODUCT- POLIGRIP COMFORT SEAL STRIPS) CREATED FOR THE SAME PATIENT/ REPORTER. CASE PRODUCT: POLIGRIP DENTURE ADHESIVE DEVICE MFR NUMBER: 1000415764-2024-00153.

Description of Event or Problem

IT'S LIKE A BIG GLOB IN MY THROAT [MEDICATION STUCK IN THROAT] NIGHT IF I SWALLOW ANY OF THAT, IT'S LIKE A BIG GLOB IN MY THROAT AND I CAN'T BREATHE [ACCIDENTAL DEVICE INGESTION] I CAN'T BREATHE [BREATHING DIFFICULT] I HAVE TO PUT TOO MUCH OF THE PRODUCT ON MY DENTURES, OTHERWISE IT DOESN'T HOLD WELL. IF I PUT TOO LITTLE IT HOLDS UNTIL THE AFTERNOON AND THEN MY DENTURES BECOME LOOSE/. I HAVE TO USE DRY PAPER TOWEL TO REMOVE THE ADHESIVE AFTERWARDS [WRONG TECHNIQUE IN DEVICE USAGE PROCESS] I HAVE ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE [DEVICE DIFFICULT TO REMOVE] PRODUCT COMPLAINT [PRODUCT COMPLAINT] CASE DESCRIPTION: ON (B)(6) 2024 A SPONTANEOUS CASE WAS REPORTED IN UNITED STATES OF AMERICA BY A PATIENT VIA CALL CENTER REPRESENTATIVE (PHONE). THE REPORT CONCERNS A CONSUMER. THE CONSUMER RECEIVED POLIGRIP DENTURE ADHESIVE POWDER (CARNA+POLMA POWDER) LOT NUMBER RR36W AND EXPIRATION DATE WAS 2025-10-31 FOR INDICATION, DENTURE WEARER. CASE PRODUCT: POLIGRIP DENTURE ADHESIVE POWDER DEVICE MFR NUMBER: NO CONCOMITANT MEDICATIONS WERE REPORTED. NO MEDICAL HISTORY WAS REPORTED. NO DRUG HISTORY WAS REPORTED. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING POLIGRIP DENTURE ADHESIVE POWDER,THE CONSUMER REPORTED AS PATIENT HAD ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE FROM THE GUMS (DEVICE DIFFICULT TO USE). ON AN UNKNOWN DATE, PATIENT REPORTED THAT, "I AM SURE I AM NOT DOING SOMETHING RIGHT BECAUSE I HAVE TO PUT TOO MUCH OF THE PRODUCT ON MY DENTURES, OTHERWISE IT DOESN'T HOLD WELL. IF I PUT TOO LITTLE IT HOLDS UNTIL THE AFTERNOON AND THEN MY DENTURES BECOME LOOSE, AND IT'S ALWAYS BEEN LIKE THAT AND PATIENT INCLUDED THAT, I HAVE TO USE DRY PAPER TOWEL TO REMOVE THE ADHESIVE AFTERWARDS" (WRONG TECHNIQUE IN DEVICE USAGE PROCESS). ON AN UNKNOWN DATE, PATIENT EXPERIENCED, OTHER MEDICALLY IMPORTANT CONDITION, ACCIDENTAL DEVICE INGESTION (REPORTED AS "DURING THE NIGHT IF I SWALLOW ANY OF THAT, IT'S LIKE A BIG GLOB IN MY THROAT"). ON AN UNKNOWN DATE, PATIENT REPORTED THAT, IT'S LIKE A BIG GLOB IN PATIENT'S THROAT AND CAN'T BREATHE (FOREIGN BODY IN THROAT (OTHER MEDICALLY IMPORTANT CONDITION) AND DYSPNEA). ON AN UNKNOWN DATE, PATIENT EXPERIENCED PRODUCT COMPLAINT. THE ACTION TAKEN WERE: FOR POLIGRIP DENTURE ADHESIVE POWDER WAS UNKNOWN. OUTCOME OF THE EVENTS WERE UNKNOWN. DECHALLENGE WAS UNKNOWN AND RECHALLENGE WAS NOT APPLICABLE. CAUSALITY ASSESSMENT 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 CASE IS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4). FOLLOW UP INFORMATION WAS RECEIVED ON 2024-06-27 FROM QUALITY ASSURANCE (QA) DEPARTMENT REGARDING PRODUCT QUALITY COMPLAINT WITH CASE NUMBER (B)(4) FOR LOT NUMBER RR36W. INVESTIGATION EVALUATION: NO SAMPLE WAS RETURNED FOR THIS COMPLAINT AND THE LOT/BATCH DETAILS WERE NOT RECEIVED SO A FULL INVESTIGATION CANNOT BE COMPLETED. AS THIS INFORMATION IS NOT AVAILABLE THE COMPLAINT CANNOT BE SUBSTANTIATED AND WILL BE CLOSED AS INCONCLUSIVE. IF THE CONSUMER CONTACTS US WITH ADDITIONAL INFORMATION OR IF THE COMPLAINT SAMPLE IS RECEIVED, THE COMPLAINT ISSUE WILL BE REOPENED AND FURTHER EVALUATED. RESPONSE TO CONSUMER: NO SAMPLE WAS RETURNED FOR THIS COMPLAINT, ALSO BATCH DETAILS WERE NOT RECEIVED SO A FULL INVESTIGATION COULD NOT BE COMPLETED. AS THIS INFORMATION IS NOT AVAILABLE THE COMPLAINT CANNOT BE SUBSTANTIATED. ALL OF THE DOCUMENTATION PERTINENT TO A SPECIFIC LOT OF FINISHED PRODUCT IS CONTAINED IN A [?]BATCH ENVELOPE'. PRIOR TO THE DISPOSITION OF THE PRODUCT, THE CONTENTS OF EACH BATCH ENVELOPE IS REVIEWED & APPROVED BY THE SITE QUALITY DEPARTMENT TO VERIFY THAT THERE WERE NO SIGNIFICANT QUALITY ISSUES RECORDED DURING MANUFACTURING, PACKAGING OR TESTING. THIS REVIEW ALSO VERIFIES THAT ALL TEST RESULTS MEET SPECIFICATION REQUIREMENTS. THE INVESTIGATION REPORTS CONCLUDED THAT, COMPLAINT STANDS INCONCLUSIVE. THE PQC NUMBER WAS REPORTED AS (B)(4) THE REPORTER PROVIDED THE FOLLOWING COMMENT: "I USE THIS POLIGRIP DENTURE ADHESIVE POWDER 1.6OZ AND THE POLIGRIP DENTURE ADHESIVE STRIPS 40CT. I HAVE USED BOTH PRODUCTS IN THE PAST AS WELL AND I HAVE ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE FROM MY GUMS. I AM NOT ABLE TO DO SO. I AM SURE I AM NOT DOING SOMETHING RIGHT BECAUSE I HAVE TO PUT TOO MUCH OF THE PRODUCT ON MY DENTURES, OTHERWISE IT DOESN'T HOLD WELL. IF I PUT TOO LITTLE IT HOLDS UNTIL THE AFTERNOON AND THEN MY DENTURES BECOME LOOSE, AND IT'S ALWAYS BEEN LIKE THAT. THIS IS WHY I ALWAYS PUT WAY TOO MUCH AND I CAN'T GET IT ALL OUT. DURING THE NIGHT IF I SWALLOW ANY OF THAT, IT'S LIKE A BIG GLOB IN MY THROAT AND I CAN'T BREATHE. I HAVE TO USE DRY PAPER TOWEL TO REMOVE THE ADHESIVE AFTERWARDS. I AM CALLING TO ASK IF YOU HAVE ANY TRICKS THAT WILL HELP ME REMOVE THE ADHESIVE EASIER?". THIS CASE IS 1 OF 2 FOR THE SAME PATIENT. THE CASES (B)(4) ARE CREATED. PLEASE SEE THE CASE (B)(4) (WITH THE SUSPECT PRODUCT- POLIGRIP COMFORT SEAL STRIPS) CREATED FOR THE SAME PATIENT/ REPORTER.

Additional Manufacturer Narrative

VEEVA CASE: (B)(4).