Description of Event or Problem · 1
A (B)(6) FEMALE COMPLAINANT WITH KNOWN ALLERGY TO PENICILLIN AND TAKING THREE MEDICATIONS FOR HIGH BLOOD PRESSURE, HIGH CHOLESTEROL AND HEART BURN REPORTED INCIDENT AFTER USING TEE VEE BRANDS LASSY LEGS .COMPLAINANT HAS USED SIMILAR BRANDS FOR YEARS WITHOUT INCIDENT. PRODUCT IS USED TO REMOVE HAIR FROM ARMS, LEGS AND MUSTACHE. COMPLAINANT HAS BEEN USING PRODUCT EVERY TWO WEEKS AND SHOPPING AT SAME RETAIL STORE OVER TWO YEARS. SHE LAST USED PRODUCT IN (B)(6) WITHOUT ISSUE. ON (B)(6) 2011, COMPLAINANT USED PRODUCT AS NORMAL ON HER ARMS AND KNUCKLES. NO OTHER CREAMS OR LOTIONS WERE APPLIED TO HER SKIN PER COMPLAINANT, THIS WAS THE ONLY PRODUCT SHE APPLIED TO HER SKIN. THE NEXT DAY, HER RIGHT ARM WAS RED. THE FOLLOWING DAY SYMPTOMS WORSENED AND HER RIGHT ARM WAS MORE DISCOLORED. BY THE THIRD DAY HER RIGHT ARM HAD SWELLED AND APPEARED BURNED FROM HER ELBOW TO HER WRIST. SHE ALSO HAD SACKS OF PUS IN SMALL BUMPS ON HER SKIN. COMPLAINANT VISITED HER DOCTOR AND WAS REFERRED TO THE BURN UNIT FOR ABRASIONS TO HER EXTERNAL SKIN. SHE WAS TREATED WITH SILVER SULFATE 1% AND PAIN RELIEVERS. THEY WRAPPED HER ARM AND SHE WAS TOLD TO APPLY CREAM TWICE PER DAY. SYMPTOMS HAVE IMPROVED. RETAILER NAME: (B)(6). PURCHASE DATE: (B)(6) 2011. PRODUCT USED EVERY TWO WEEKS.