ORASURE ORAL SPECIMEN COLLECTION DEVICE

Description of Event or Problem

ON 10/20/2000 AT ABOUT NOON MOUNTAIN TIME, A TEST SUBJECT PROVIDED AN ORAL FLUID SAMPLE WITH THE ORASURE ORAL SPECIMEN COLLECTION DEVICE FOR INSURANCE PURPOSES. THE TEST SUBJECT BROKE OUT WITH HIVES (REDNESS OF SKIN AND A RASH ALL OVER THEIR BODY) AND A TINGLING SENSATION THROUGHOUT THEIR BODY 20-30 MINUTES LATER. THE FAMILY MEMBER OF THE TEST SUBJECT REPORTED THE INCIDENT TO THE OFFICE OF THE COLLECTING INSURANCE AGENT AT APPROXIMATELY 2:30 P.M. MOUNTAIN TIME. ACCORDING TO THE FAMILY MEMBER, THE TEST SUBJECT HAS NO KNOWN ALLERGIES AND WAS NOT EXPOSED TO ANYTHING OUT OF THE ORDINARY. THE TEST SUBJECT DID NOT RECEIVE MEDICAL ATTENTION. AN INSURANCE CO REP REPORTED THE COMPLAINT TO COMPANY, THE MFR. FACILITY INSTRUCTED THE INSURANCE REP TO ADVISE THE TEST SUBJECT TO SEEK MEDICAL ATTENTION IF THE SYMPTOMS PERSIST OR GET WORSE. ON 10/20/2000 AT 2:00 P.M. PACIFIC STANDARD TIME, COMPLAINT COORDINATOR FOR THE MFR INTERVIEWED THE TEST SUBJECT. THE TEST SUBJECT FEELS THE REACTION COULD HAVE BEEN DUE TO A NUMBER OF THINGS, INCLUDING SOMETHING THEY ATE. PT'S FAMILY MEMBER REPORTED THE COMPLAINT AND ACCORDING TO PT, FAMILY MEMBER WAS OVER-REACTING. THE TEST SUBJECT TOOK A COUPLE OF TYLENOL AND WAS FEELING BETTER. THE REDNESS WAS GOING AWAY. FACILITY INFORMED THE TEST SUBJECT THE INGREDIENTS OF THE DEVICE AND INFORMED THEM THAT THE DEVICE CONTAINED THE POTENTIAL ALLERGEN OF GELATIN. FACILITY PROVIDED EXAMPLES OF FOODS THAT MIGHT CONTAIN GELATIN. FACILITY OFFERED TO SEND THEM A LIST OF THE INGREDIENTS AND TO HAVE CO'S CONSULTING PHYSICIAN CONTACT THEM. PT SAID THEY WERE FEELING BETTER AND IT WOULD NOT BE NECESSARY TO SEND THE LIST OR HAVE CONSULTING PHYSICIAN CONTACT THEM. THE TEST SUBJECT THANKED FACILITY FOR CALLING AND HUNG UP THE PHONE.