ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

Description of Event or Problem

TEST SUBJECT PROVIDED AN ORAL FLUID SAMPLE WITH THE ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE FOR THE PURPOSE OF HIV TESTING AROUND THE BEGINNING OF 2001. A TRAINED HIV COUNSELOR AT THE USER FACILITY ADMINISTERED THE COLLECTION. COUNSELORS AT THE USER FACILITY ARE TRAINED ACCORDING TO THE PRODUCT INSERT AND WEAR GLOVES WHILE ADMINISTERING THE COLLECTION. THE TEST SUBJECT PLACED THE COLLECTION PAD INSIDE THE LOWER RIGHT SIDE OF THE TEST SUBJECT'S MOUTH BETWEEN CHEEK AND GUM. THE PAD WAS RUBBED BACK AND FORTH UNTIL MOIST. THE PAD WAS LEFT IN TEST SUBJECT'S MOUTH FOR THREE MINUTES. AFTER THE THREE MINUTES THE COLLECTION PAD WAS REMOVED AND PLACED INTO THE SPECIMEN VIAL. THE COLLECTION WAS PERFORMED ACCORDING TO THE PRODUCT INSERT. THE TEST SUBJECT RECALLS THE SALTY TASTE OF THE COLLECTION PAD, AND THE SALTY TASTE REMAINED WITH TEST SUBJECT DURING TEST SUBJECT'S NON-SPICY MEAL TEST SUBJECT ATE SHORTLY AFTER PROVIDING THE COLLECTION. APPROXIMATELY ONE AND A HALF DAYS AFTER PROVIDING THE COLLECTION, THE TEST SUBJECT NOTED THAT EACH SIDE OF TEST SUBJECT'S TONGUE WAS RED WITH SMALL BLISTER-LIKE INFLAMMATION (ULCERS). AFTER THIS OCCURRENCE, THE TEST SUBJECT IS STILL EXPERIENCING THE SYMPTOMS. THE TEST SUBJECT INFORMED THE COMPANY THAT TEST SUBJECT HAS SEEN TWO MEDICAL DOCTOR'S REGARDING TEST SUBJECT'S CONDITION. TEST SUBJECT STATED THAT THE FIRST DOCTOR WAS NOT SURE OF THE CAUSE OR SYMPTOMS. THE SECOND DOCTOR TOOK A CULTURE SAMPLE AND THE TEST SUBJECT HAS A FOLLOW UP APPOINTMENT IN 2001 FOR THE RESULTS.