IRASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

Description of Event or Problem

A TEST SUBJECT PROVIDED AN ORAL FLUID SAMPLE WITH THE ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE FOR INSURANCE PURPOSES IN 2001. THE COLLECTION WAS PERFORMED ACCORDING TO THE PRODUCT INSERT. THE TEST SUBJECT WAS PROVIDED THE COLLECTION PAD. THEY PROCEEDED TO PLACE THE PAD BETWEEN THEIR LOWER CHEEK AND GUMLINE. THEY RUBBED THE PAD BACK AND FORTH A FEW TIMES UNTIL IT WAS MOIST. THE COLLECTION PAD WAS THEN LEFT STATIONARY FOR 3 MINUTES. AFTER THE THREE MINUTES, THE TEST SUBJECT REMOVED THE COLLECTION PAD FROM THEIR MOUTH AND PLACED IT IN THE SPECIMEN VIAL. THE TEST SUBJECT STATED THAT THE DEVICE STUCK TO THEIR CHEEK AS THEY REMOVED IT, AND THE REMOVAL WAS SLIGHTLY PAINFUL. THE POINT OF CONTACT WITH THE DEVICE FELT IRRITATED AND PROCEEDED TO FEEL WORSE THROUGHOUT THE DAY. THEY DID NOT EAT FOODS OUT OF THE ORDINARY FOR THEM THAT DAY. THE IRRITATION IS SENSITIVE TO ACIDIC FOODS AND SODA. THE TEST SUBJECT DESCRIBES THEIR REACTION TO ACIDIC FOODS AS SMALL BLISTERS AT THE SITE OF THE IRRITATION. SOMETIME AFTER THE COLLECTION THE TEST SUBJECT WAS SCHEDULED TO HAVE ORAL SURGERY, BUT THEIR DENTIST POSTPONED THE SURGERY UNTIL THEIR IRRITATION HEALED. THE DENTIST INFORMED THEM THAT IT APPEARED THAT LAYERS OF SKIN HAD BEEN REMOVED. THE DENTIST SUGGESTED THAT THEY VISIT AN ORAL SPECIALIST REGARDING THE IRRITATION. AT THIS POINT, THE PT'S FAMILY MEMBER REPORTED THE COMPLAINT TO THE USER FACILITY 11 1/2 WEEKS LATER. THE ORAL SPECIALIST WAS NOT ABLE TO DETECT THE IRRITATION. THE TEST SUBJECT IS PLANNING TO SEE A SECOND ORAL SPECIALIST. AS OF 8/2001, THE TEST SUBJECT STATED THAT THE IRRITATION IS STILL SENSITIVE TO ACIDIC FOODS AND SODA. THE CO HAS ATTEMPTED TO CONTACT AND FOLLOW-UP WITH THE TEST SUBJECT 3 TIMES IN 8/2001.