ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

Description of Event or Problem

A TEST SUBJECT PROVIDED AN ORAL FLUID SAMPLE WITH THE COLLECTION DEVICE IN 2001 AT A CLINIC. THE COLLECTION ADMINISTRATOR PROVIDED THE COLLECTION DEVICE TO THE TEST SUBJECT. THE TEST SUBJECT PROCEEDED TO PLACE THE DEVICE IN PT'S MOUTH BETWEEN THE LOWER CHEEK AND GUMLINE. AFTER RUBBING IT BACK AND FORTH UNTIL THE COLLECTION PAD WAS MOIST, THE SUBJECT LEFT THE PAD STATIONARY IN PT'S MOUTH FOR TWO MINUTES. AFTER TWO MINUTES, PT REMOVED THE DEVICE AND PLACED IT IN THE SPECIMEN VIAL. COLLECTION PERFORMED ACCORDING TO THE PRODUCT INSERT. APPROXIMATELY FIFTEEN MINUTES TO ONE HOUR LATER PT EXPERIENCED AN ITCHING SENSATION ALONG WITH REDNESS AND SWELLING AT THE BACK OF THE LEGS AND ARMS. EXPERIENCED DERMATOGRAPHISM-A FORM OF URTICARIA IN WHICH WHEALING OCCURS IN THE SITE AND IN THE CONFIGURATION OF APPLICATION OF STROKING (PRESSURE, FRICTION) OF THE SKIN. THE URTICARIA DECREASED OVER THE NEXT TWO DAYS. THE TEST SUBJECT WENT TO PT'S DOCTOR. THE DOCTOR INFORMED PT THAT PT PROBABLY HAD AN ALLERGIC REACTION TO THE DEVICE BECAUSE PT WAS EXPOSED TO NOTHING ELSE OUT OF THE ORDINARY THAT DAY. THE DOCTOR DID NOT PROVIDE MEDICATION FOR THE SYMPTOMS. THE URTICARIA RESOLVED APPROX ONE WEEK LATER. OF THE DEVICE CONSTITUENTS, ONLY GELATIN IS A POTENTIAL ALLERGEN. THE TEST SUJECT HAS NO KNOWN ALLERGIES TO GELATIN. THE TEST SUBJECT FELT THE ISSUE WAS CLOSED AND DECLINED CO'S OFFER TO HAVE CO'S CONSULTING PHYSICIAN TO CONTACT PT.