ORASURE HIV-1 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 01/2001. THE COMPLAINANT HAD SLURRED SPEECH AND REALIZED THAT THEIR TONGUE WAS SWOLLEN AND COVERED WITH CANKER SORES. PT TOOK BENADRYL IN RESPONSE TO THE SWELLING AND CANKER SORES. THE CANKER SORES AND SWOLLEN TONGUE CLEARED AND IT WAS A SHORT TERM REACTION. AT THE TIME OF THE COLLECTION PT WAS TAKING ERYTHROMYCIN PRESCRIBED BY THEIR DENTIST FOR AN INFECTION FOLLOWING ORAL SURGERY. PT WAS ALSO TAKING ADVIL LIQUID GELATIN CAPSULES. THE ERYTHROMYCIN WAS ALSO GELATIN CAPSULES. THE TEST SUBJECT WAS NOT SURE WHAT CAUSED THE REACTION. PT WAS INFORMED OF THE INGREDIENTS OF THE DEVICE AND THE POTENTIAL ALLERGEN OF GELATIN. AFTER REPORTING THE COMPLAINT, THE TEST SUBJECT DISCONTINUED THE USE OF THE ERYTHROMYCIN AND THE ADVIL (ALL THEIR MEDICATIONS WITH GEL CAPSULES). THE TEST SUBJECT BELIEVES THEY MIGHT BE ALLERGIC TO GELATIN, PT STATED THAT THEY HAVE REACTIONS TO MEDICINE CONTAINED IN GELATIN CAPSULES. PT REPORTED THE COMPLAINT ON WEDNESDAY, 2/01 AND ON NEXT DAY PT STILL HAD SOME ITCHING SIMILAR TO WHAT PT EXPERIENCES AFTER TAKING GELATIN CAPSULES. 2 DAYS LATER, IN 02/2001, PT WAS FREE OF ALL SYMPTOMS. PT SOUGHT THE ADVISE OF THEIR DENTIST AND A PEDIATRICIAN. PT'S DENTIST AND THE PEDIATRICIAN, AGREED THAT THE DISCONTINUATION OF THE ANTIBIOTIC AND ADVIL WAS THE CORRECT ACTION.