Description of Event or Problem · 1
A 64 YEAR OLD MALE CONSUMER WHO HAS AN ALLERGY TO PENICILLIN AND TAKES ATENOLOL FOR HYPERTENSION REPORTED THAT HE HAS USED POLIDENT OVERNIGHT. DENTURE CLEANSER TO CLEAN HIS DENTURE APPROXIMATELY ONCE EVERY WEEK OR ONCE EVERY 2 WEEKS FOR THE PAST 3 YEARS AND HAS EXPERIENCED ANGIOEDEMA, HIVES, THROAT SWELLING, LIP SWELLING, AND PARESTHESIA ON OCCASION OVER THE PAST 2 YEARS. THE CONSUMER REPORTED THAT APPROXIMATELY 15 TO 20 TIMES PER YEAR OVER THE PREVIOUS 2 YEARS HE HAS EXPERIENCED EPISODES OF DIAGNOSED "UNEXPLAINED ANGIOEDEMA." THE CONSUMER REPORTED THAT EACH EPISODE OF ANGIOEDEMA IS VARIABLE AND HAS INVOLVED DIFFERENT BODY SITES AT ONE TIME OR ANOTHER. THE CONSUMER REPORTED THAT THERE IS NO PATTERN TO THE FREQUENCY OF THESE EPISODES AND THAT SOMETIMES HE EXPERIENCES THEM DAYS APART OR WEEKS APART. THE CONSUMER REPORTED THAT HE HAS NEVER CORRELATED POLIDENT OVERNIGHT USE WITH THE ONSET OF ANY OF THESE EPISODES. THE CONSUMER REPORTED THAT A TYPICAL EPISODE STARTS WITH A "TINGLING" SENSATION WHICH LASTS FOR APPROXIMATELY 6 HRS AND IS FOLLOWED BY SWELLING AND HIVES OF THE AFFECTED AREA. THE CONSUMER REPORTED THAT THESE EPISODES HAVE AFFECTED AT ONE TIME OR ANOTHER HIS BACK, ELBOW, FOOT, EAR, AND MOST FREQUENTLY HIS FACE, EYES, LIP, AND TONGUE. THE CONSUMER REPORTED THAT EACH EPISODE TYPICALLY INVOLVES ONE OF THE ABOVE MENTIONED BODY SITES AT A TIME, AND HE DOES NOT EXPERIENCE MULTIPLE-SITE EPISODES. THE CONSUMER REPORTED THAT HIS SWELLING AND HIVES TYPICALLY HAVE RESOLVED IN 1 DAY WITH OR WITHOUT MEDICAL TREATMENT. THE CONSUMER REPORTED THAT HE DID NOT EXPERIENCE ITCHING DURING THESE EPISODES. THE CONSUMER REPORTED THAT HE EXPERIENCED 2 EPISODES OF THROAT SWELLING OVER THE PREVIOUS 2 YEARS. THE CONSUMER REPORTED THAT ON BOTH OCCASIONS THE ENTIRE BACK OF HIS THROAT STARTED TO SWELL, AND APPROXIMATELY 30 MINS LATER HE EXPERIENCED DIFFICULTY BREATHING. THE CONSUMER REPORTED THAT HE SOUGHT TREATMENT AT AN ER BOTH TIMES AND WAS GIVEN INTRAVENOUS BENADRYL, EPINEPHRINE AND PREDINSONE. THE CONSUMER REPORTED THAT HIS THROAT SWELLING RESOLVED APPROXIMATELY 4 HRS AFTER TREATMENT. THE CONSUMER REPORTED THAT HE DID NOT EXPERIENCE TONGUE SWELLING DURING EITHER OF THESE 2 EPISODES. THE CONSUMER REPORTED THAT HE HAD NOT USED POLIDENT OVERNIGHT DIRECTLY PRIOR TO EXPERIENCING HIS THROAT SWELLING IN EITHER OF THESE TWO INSTANCES. THE CONSUMER REPORTED THAT HE HAS SOUGHT MEDICAL TREATMENT FOR ALL OF HIS SYMPTOMS. THE CONSUMER REPORTED THAT HIS PHYSICIAN HAD HIM DOCUMENT ANY FOOD, MEDICATION, OR PRODUCT THAT HE INGESTED OR CAME IN CONTACT WITH, BUT HIS PHYSICIAN HAS BEEN UNABLE TO IDENTIFY A CAUSATIVE FACTOR. THE CONSUMER REPORTED THAT HE HAS NOT CHANGED HIS DIETARY HABITS OVER THE PREVIOUS 2 YEARS. THE CONSUMER REPORTED THAT HIS PHYSICIAN DIAGNOSED HIM WITH "UNEXPLAINED ANGIOEDEMA." THE CONSUMER REPORTED THAT HIS PHYSICIAN REQUESTED A COPY OF THE INGREDIENT LIST FOR POLIDENT OVERNIGHT AND HAS NOT INSTRUCTED THE CONSUMER TO DISCONTINUE PRODUCT USE. THE MFR SUPPLIED A LIST OF POLIDENT OVERNIGHT INGREDIENTS TO THE CONSUMER AND ADVISED THE CONSUMER TO DISCONTINUE PRODUCT USE. THE CONSUMER REPORTED THAT HIS PHYSICIAN REVIEWED THE INGREDIENT LIST AND DID NOT ATTRIBUTE THE CONSUMER'S SYMPTOMS TO PRODUCT USE. THE CONSUMER REPORTED THAT HIS PHYSICIAN PRESCRIBED FOR HIM ZYRTEC SYRUP TO TAKE IN THE EVENT THAT HE EXPERIENCES ANOTHER EPISODE OF ANGIOEDEMA.