POLIGRIP POWER MAX HOLD AND SEAL

Description of Event or Problem

ANAPHYLACTIC SHOCK [ANAPHYLACTIC SHOCK] ANAPHYLAXIS [ANAPHYLAXIS] MILD ITCHING [ITCHING]. CASE DESCRIPTION: ON (B)(6) 2025 A SPONTANEOUS CASE WAS REPORTED IN UNITED STATES OF AMERICA BY A CONSUMER OR OTHER NON-HEALTH PROFESSIONAL VIA OTHER MANUAL SOURCE. THE REPORT CONCERNS A CONSUMER OF UNKNOWN AGE AND GENDER. THE CONSUMER RECEIVED POLIGRIP POWER MAX HOLD AND SEAL (CARNA+POLMA CREAM) WITH UNKNOWN LOT NUMBER AND EXPIRY DATE FOR UNKNOWN INDICATION. CONCOMITANT DRUG INCLUDE FIXODENT WITH UNKNOWN LOT NUMBER AND EXPIRY DATE FOR UNKNOWN INDICATION. NO DRUG HISTORY AND MEDICAL HISTORY WERE REPORTED. ON AN UNKNOWN DATE IN 2025, WITHIN 3 MINUTES OF APPLYING POLIGRIP POWER MAX HOLD AND SEAL, THE CONSUMER EXPERIENCED SERIOUS EVENT, MILD ITCHING (PREFERRED TERM: PRURITUS) WITH SERIOUSNESS LIFE THREATENING AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). ON AN UNKNOWN DATE IN 2025, AFTER AN UNKNOWN TIME OF STARTING POLIGRIP POWER MAX HOLD AND SEAL, THE CONSUMER EXPERIENCED SERIOUS EVENTS, ANAPHYLAXIS (PREFERRED TERM: ANAPHYLACTIC REACTION) AND ANAPHYLACTIC SHOCK (PREFERRED TERM: ANAPHYLACTIC SHOCK) WITH SERIOUSNESS LIFE THREATENING, OTHER MEDICALLY IMPORTANT CONDITION AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). THE OUTCOME OF THE EVENTS PRURITUS, ANAPHYLACTIC REACTION AND ANAPHYLACTIC SHOCK WERE UNKNOWN. THE ACTION TAKEN FOR POLIGRIP POWER MAX HOLD AND SEAL WAS UNKNOWN. THE DE-CHALLENGE WAS ASSESSED AS UNKNOWN AND RECHALLENGE WAS ASSESSED AS NOT APPLICABLE FOR ALL EVENTS. THE CAUSALITY OF THE EVENTS PRURITUS, ANAPHYLACTIC REACTION AND ANAPHYLACTIC SHOCK WITH RESPECT TO THE SUSPECT POLIGRIP POWER MAX HOLD AND SEAL WAS REASONABLE POSSIBILITY. THIS REPORT IS MADE BY HALEON WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. CASE PRODUCT: POLIGRIP POWER MAX HOLD AND SEAL DEVICE MFR NUMBER: 1000415764-2025-00270. THE REPORTER PROVIDED THE FOLLOWING COMMENT: "AFTER PROLONGED, CONSISTENT USE, I EXPERIENCED ANAPHYLAXIS AFTER USING POLIGRIP POWER MAX. I HAD TWO UNEXPLAINED MILD ALLERGIC REACTIONS IN THE EVENING THE WEEK PRIOR THAT WERE RESPONSIVE TO OTC ANTIHISTAMINES AND WAS CLOSELY MONITORING FOOD AND ENVIRONMENTAL FACTORS TO DETERMINE THE SOURCE OF THE ALLERGIC REACTIONS. MY USUAL ROUTINE IS TO USE FIXODENT IN THE AM AND POLIGRIP BEFORE DINNER. IN A RUSH, I APPLIED THE POLIDENT IN THE MORNING AND WITHIN 3 MINUTES DEVELOPED THE MILD ITCHING FROM THE WEEK PRIOR, WHICH QUICKLY PROGRESSED TO ANAPHYLAXIS WHILE I WAS HOME ALONE. I WAS BARELY ABLE TO CALL BEFORE GOING INTO ANAPHYLACTIC SHOCK. IT TOOK CLOSE TO AN HOUR TO STABILIZE ME FOR AMBULANCE TRANSPORT, I ALMOST HAD TO BE INTUBATED DUE TO THE SEVERITY OF THE REACTION, AND THE MEDICAL STAFF HAD DIFFICULTY KEEPING MY BLOOD PRESSURE ABOVE 70 OVER 30 AFTER I ARRIVED IN THE ER. THIS WAS NEARLY A FATAL REACTION. I HAVE NO HISTORY OF ALLERGIES. I'M CONCERNED I HAD A "BAD BATCH" OF THE PRODUCT. I HADN'T EATEN SINCE DINNER THE NIGHT BEFORE AND HAD ONLY HAD A CUP OF COFFEE FROM THE SAME CANISTER I'D BEEN USING FOR WEEKS, AND A FEW SIPS OF DIET PEPSI POURED INTO A THERMAL CUP THE PREVIOUS DAY FROM A LARGE BOTTLE I'D BEEN USING FOR 3 DAYS WITH NO REACTIONS."

Additional Manufacturer Narrative

VEEVA CASE: (B)(4).