D
Patient 1
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A (B)(6) FEMALE CONSUMER REPORTING ON SELF FROM (B)(6). THE MEDICAL HISTORY OF THE CONSUMER INCLUDED SCLERODERMA SINCE (B)(6), RHEUMATOID ARTHRITIS, REFLUX, STRICTURE AND SHE WAS ALLERGIC TO PERFUME, CIGARETTE SMOKE, CAR EXHAUST, MANY CHEMICALS IN CLEANING SUPPLIES, FORMALDEHYDE AND ALL SCENTED PRODUCTS. THE CONCOMITANT MEDICATIONS ASPIRIN TWICE TO THRICE A DAY FOR TWENTY YEARS FOR ARTHRITIS AND PRILOSEC (OMEPRAZOLE) FIFTEEN (SIC), FOUR TIMES A DAY FOR REFLUX AND STRICTURE. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING CAREFREE BODY SHAPE EXTRA LONG PANTILINERS CUTANEOUSLY, ONE PAD, THRICE A DAY FOR A LITTLE URINARY INCONTINENCE (OFF LABEL USE) (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE GOT CONFUSED AND DEVELOPED SLURRED SPEECH, GIBBERISH SPEAK, HEADACHE, AGGRAVATION OF ARTHRITIS, SWELLING OF HANDS AND DIFFICULTY IN BENDING FINGERS. SHE ALSO STATED THAT THE DEVICE HAD ABNORMAL SMELL. SHE WAS USING THE DEVICE SINCE TEN YEARS. THE EVENTS RESOLVED AFTER ONE TO THREE HOURS. AFTER AN UNSPECIFIED DURATION, ABOUT A MONTH AGO, SHE DISCONTINUED THE USE OF DEVICE. THIS REPORT WAS ASSESSED AS SERIOUS. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE.