POLIGRIP COMFORT SEAL

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]. IF I SWALLOW ANY OF THAT, IT'S LIKE A BIG GLOB IN MY THROAT [ACCIDENTAL DEVICE INGESTION]. I CAN'T BREATHE [BREATHING DIFFICULT]. I HAVE ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE FROM MY GUMS. [DEVICE DIFFICULT TO REMOVE]. I HAVE TO PUT TOO MUCH OF THE PRODUCT ON MY DENTURES/ IF I PUT TOO LITTLE IT HOLDS UNTIL THE AFTERNOON. 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 FROM MY GUMS. I AM NOT ABLE TO DO SO [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). ON (B)(6) 2024, NEW INFORMATION WERE RECEIVED FOR THIS CASE. THE REPORT CONCERNS A CONSUMER. THE CONSUMER RECEIVED POLIGRIP COMFORT SEAL (CARNA+MACL STRIP) LOT NUMBER: 1807391 AND EXPIRY DATE 2026-09-01 FOR INDICATION DENTURE WEARER. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING POLIGRIP COMFORT SEAL STRIPS, THE CONSUMER EXPERIENCED A MEDICALLY SIGNIFICANT, FOREIGN BODY IN THROAT (IT'S LIKE A BIG GLOB IN MY THROAT). THE OUTCOME OF THE EVENT FOREIGN BODY IN THROAT WAS UNKNOWN. ON AN UNKNOWN DATE, THE CONSUMER EXPERIENCED A MEDICALLY IMPORTANT CONDITION ACCIDENTAL DEVICE INGESTION (IF I SWALLOW ANY OF THAT, IT'S LIKE A BIG GLOB IN MY THROAT). THE OUTCOME OF THE EVENT ACCIDENTAL DEVICE INGESTION WAS UNKNOWN. ON AN UNKNOWN DATE, THE CONSUMER EXPERIENCED A NON SERIOUS DYSPNOEA (I CAN'T BREATHE), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (I HAVE TO PUT TOO MUCH OF THE PRODUCT ON MY DENTURES/ IF I PUT TOO LITTLE IT HOLDS UNTIL THE AFTERNOON/I HAVE TO USE DRY PAPER TOWEL TO REMOVE THE ADHESIVE AFTERWARDS), DEVICE DIFFICULT TO USE (I HAVE ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE FROM MY GUMS) 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 EVENTS DYSPNOEA, WRONG TECHNIQUE IN DEVICE USAGE PROCESS, DEVICE DIFFICULT TO USE AND PRODUCT COMPLAINT WAS UNKNOWN. NO MEDICAL HISTORY WAS REPORTED. NO DRUG HISTORY WAS REPORTED. THE ACTION TAKEN WERE: FOR POLIGRIP COMFORT SEAL STRIPS WAS UNKNOWN. DECHALLENGE WAS UNKNOWN AND RECHALLENGE WAS NOT APPLICABLE FOR ALL THE EVENTS. REPORTER CAUSALITY OF THE EVENT WAS NOT REPORTED/NOT ASSESSABLE FOR ALL THE EVENTS. 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 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". ON 2024-07-13, THE FOLLOWING UPDATES HAVE BEEN PROVIDED - FOLLOW UP INFORMATION WAS RECEIVED FROM QUALITY ASSURANCE (QA) DEPARTMENT ON 2024-07-13 REGARDING COMPLAINT (B)(4) FOR LOT NUMBER: 1807391. INVESTIGATION EVALUATION: ON (B)(6) 2024 18:18:45: CONCLUSION/ROOT CAUSE: THE FOLLOWING DOCUMENTS WERE REVIEWED UPON RECEIPT OF COMPLAINT: DHR BATCH RECORDS FOR LOT#: 0001807391, SCAPA COC FOR LOT#: 0001807391, SCAPA COA FOR LOT#: 0001807391, LAB TEST RESULTS FOR SHIONOGI MATERIAL LOTS: 23K0307 AND 23K0108. CONCLUSION: FOR THIS COMPLAINT INVESTIGATION, DHR BATCH RECORDS FOR LOT#: 0001807391 WERE REVIEWED WITH THE FOLLOWING RESULTS. NO DEVIATIONS WERE FOUND THAT MAY INFLUENCE THE RELEASE OR EFFECTIVENESS OF THIS PRODUCT (SEE COC FOR RESULTS). ALL PHYSICAL TESTING REQUIREMENTS (FTIR, LOSS OF DRYING, ALL DIMENSIONAL AND WEIGHT SPECS) WERE MET (SEE COA AND VENDOR BATCH TESTING RECORDS FOR RESULTS). BATCH INFORMATION WAS REVIEWED TO VERIFY PRODUCT EXPIRATION DATE WAS NOT SURPASSED. OVERALL REVIEW OF LINE START ENTRIES, MATERIAL CORRECTNESS, AND FIRST ARTICLE SAMPLES ARE IN ORDER. NOTE: NO SAMPLES WERE PROVIDED, AND WE ARE UNABLE TO REVIEW OR TEST FOR PRODUCT TEXTURE AS PERFORMED DURING OUR MANUFACTURING AND PACKAGING OF THIS PRODUCT. AS A RESULT, WE ARE UNABLE TO FURTHER INVESTIGATE THIS ISSUE, AND IS CONSIDERED TO BE UNSUBSTANTIATED. COMPLAINT CONCLUSION: UNSUBSTANTIATED. THE PQC NUMBER WAS REPORTED AS (B)(4). CASE PRODUCT: POLIGRIP COMFORT SEAL DEVICE MFR NUMBER: 3004699328-2024-00013. 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 DENTURE ADHESIVE POWDER) CREATED FOR THE SAME PATIENT/ REPORTER.

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] PRODUCT COMPLAINT [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). THE REPORT CONCERNS CONSUMER. THE CONSUMER RECEIVED POLIGRIP COMFORT SEAL STRIPS (CARNA+MACL STRIP) LOT NUMBER 1807391 FOR INDICATION DENTURE WEARER. NO CONCOMITANT MEDICATIONS WERE REPORTED. CASE PRODUCT: POLIGRIP COMFORT SEAL STRIPS DEVICE MFR NUMBER: 3004699328-2024-00013. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING POLIGRIP COMFORT SEAL STRIPS, THE CONSUMER EXPERIENCED A MEDICALLY SIGNIFICANT, IT'S LIKE A BIG GLOB IN MY THROAT (PREFERRED TERM: FOREIGN BODY IN THROAT). THE OUTCOME OF THE EVENT IT'S LIKE A BIG GLOB IN MY THROAT WAS UNKNOWN. ON AN UNKNOWN DATE, THE CONSUMER EXPERIENCED A MEDICALLY IMPORTANT CONDITION, NIGHT IF I SWALLOW ANY OF THAT, IT'S LIKE A BIG GLOB IN MY THROAT AND I CAN'T BREATHE., (PREFERRED TERM: ACCIDENTAL DEVICE INGESTION). THE OUTCOME OF THE EVENT NIGHT IF I SWALLOW ANY OF THAT, IT'S LIKE A BIG GLOB IN MY THROAT AND I CAN'T BREATHE. WAS UNKNOWN. ON AN UNKNOWN DATE, THE CONSUMER EXPERIENCED A NON SERIOUS I HAVE TO PUT TOO MUCH OF THE PRODUCT ON MY DENTURES/ IF I PUT TOO LITTLE IT HOLDS UNTIL THE AFTERNOON/I HAVE TO USE DRY PAPER TOWEL TO REMOVE THE ADHESIVE AFTERWARDS, I HAVE ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE FROM MY GUMS, PRODUCT COMPLAINT, AND I CAN'T BREATHE, (PREFERRED TERM: WRONG TECHNIQUE IN DEVICE USAGE PROCESS, DEVICE DIFFICULT TO USE, PRODUCT COMPLAINT, AND DYSPNOEA). THE OUTCOME OF THE EVENT I HAVE TO PUT TOO MUCH OF THE PRODUCT ON MY DENTURES/ IF I PUT TOO LITTLE IT HOLDS UNTIL THE AFTERNOON/I HAVE TO USE DRY PAPER TOWEL TO REMOVE THE ADHESIVE AFTERWARDS, I HAVE ALWAYS STRUGGLED WITH REMOVING THE ADHESIVE FROM MY GUMS., PRODUCT COMPLAINT, AND I CAN'T BREATHE WAS UNKNOWN. NO MEDICAL HISTORY WAS REPORTED. NO DRUG HISTORY WAS REPORTED. THE ACTION TAKEN WERE: FOR POLIGRIP COMFORT SEAL STRIPS WAS UNKNOWN. DECHALLENGE WAS UNKNOWN AND RECHALLENGE WAS NOT APPLICABLE. CAUSALITY WAS REASONABLE POSSIBILITY FOR EVENTS FOREIGN BODY IN THROAT, DYSPNOEA AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS, DEVICE DIFFICULT TO USE, PRODUCT COMPLAINT, ACCIDENTAL DEVICE INGESTION WAS NOT REPORTED/ NOT ASSESSABLE WITH SUSPECT PRODUCT. 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). 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 DENTURE ADHESIVE POWDER) CREATED FOR THE SAME PATIENT/ REPORTER.