Description of Event or Problem · 1
THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF POSSIBLE ALLERGY IN A (B)(6) FEMALE PATIENT WHO USED SUPER POLIGRIP FREE (FORMULA (B)(4)) DENTURE ADHESIVE CREAM AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED SEA BOND DENTURE ADHESIVE. ON (B)(6) 2009, THE PATIENT RECEIVED DENTURES AND STATED, THE DENTIST PUT "SOMETHING ON THEM." SHE ALSO USED TWO SMALL SAMPLE SIZE TUBES OF AN UNKNOWN DENTURE ADHESIVE BEFORE SHE BEGAN USING SUPER POLIGRIP FREE CREAM ON AN UNKNOWN DATE. AN UNKNOWN TIME LATER, EXPERIENCED TROUBLE BREATHING, BEING SICK, WEAKNESS, SWOLLEN TONGUE, COUGHING AT NIGHT, GAGGING, AND COUGHING UP "HALF A CUP OF PHLEGM THAT IS NOT FROM THE STOMACH." SHE FELT THIS COULD BE DUE TO AN ALLERGY TO SUPER POLIGRIP FREE AND STATED THAT WHEN SHE HAD TROUBLE BREATHING, SHE HAD AN ANXIETY ATTACK. THE PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT THREE TIMES, AT AN URGENT CARE CLINIC THREE TIMES, AND ADMITTED TO THE HOSPITAL FROM THE EMERGENCY DEPARTMENT IN (B)(6) 2009. SHE WAS KEPT THERE FROM 4 AM TO 2 PM, HAD UNSPECIFIED BLOOD TESTS, AND WAS DISCHARGED TO HOME. SHE REPORTED THAT SHE WAS TREATED WITH SOMETHING THAT LOOKED LIKE "SMOKE," ALPRAZOLAM, AN UNSPECIFIED ALLERGY MEDICATION, UNSPECIFIED OVER-THE-COUNTER MEDICATIONS, AND AN UNSPECIFIED INHALER. THE PATIENT ALSO REPORTED, A WEIGHT LOSS FROM (B)(6) AT PRESENT. SHE SAW AN ALLERGY PHYSICIAN WITH NO FINDINGS. AT THE TIME OF REPORTING, THE PATIENT CONTINUED TO USE SUPER POLIGRIP FREE ONLY WHEN SHE WAS EATING OUT. SHE STATED HER DENTURES NEVER FIT RIGHT AND WERE PAINFUL, SO SHE DID NOT WEAR THEM OFTEN. THE EVENTS WERE HAPPENING LESS OFTEN, "ONCE IN A WHILE," OR ABOUT ONE TO TWO TIMES A WEEK SINCE SHE BEGAN TAKING ALPRAZOLAM. THE PATIENT STATED, SHE NO LONGER TOOK THE ALLERGY MEDICATION, THE OVER-THE-COUNTER MEDICATION, OR THE INHALER. MANUFACTURER'S COMMENT: SUPER POLIGRIP FREE IS MANUFACTURED IN (B)(4) AND THE PRODUCT WAS NOT AVAILABLE. (B)(4).