ORASURE 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 SPECIMENT COLLECTION DEVICE IN 2000. THE NEXT MORNING, THE TEST SUBJECT(S) CALLED THE COLLECTION ADMINISTRATOR AND COMPLAINED OF UNILATERAL EXTERNAL JAW PAIN AT THE SITE OF CONTACT OF THE COLLECTION DEVICE. IT FELT AS IF THE TEST SUBJECT(S) HAD AN ABSCESS TOOTH. THE TEST SUBJECT HAD NO INTRA ORAL PAIN OR LESIONS. IN 2000, THE ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE WAS PLACED IN THE MOUTH OF THE TEST SUBJECT BETWEEN THE LOWER CHEEK AND GUM. THE COTTON COLLECTION PAD WAS RUBBED BACK AND FORTH ALONG THE GUMLINE UNTIL IT WAS MOIST AND THEN IT WAS ALLOWED TO SIT BETWEEN THE LOWER CHEEK AND GUM FOR 3.5 TO 4.5 MINUTES. THE COLLECTION DEVICE WAS USED IN ACCORDANCE WITH THE PRODUCT INSERT. THE NEXT MORNING, THE TEST SUBJECT REPORTED THE INCIDENT TO THE TEST ADMINISTRATOR. THE TEST ADMINISTRATOR ADVISED THE TEST SUBJECT(S) TO CONTACT THE MFR AND REPORT THE INCIDENT. THE SAME DAY, THE TEST SUBJECT WAS INFORMED BY THE MFR OF THE INGREDIENTS OF THE DEVICE AND OFFERED THE OPPORTUNITY TO SPEAK WITH THE MFR'S CONSULTING PHYSICIAN. THE TEST SUBJECT WAS ADVISED TO SEEK MEDICAL ATTENTION IF THE TEST SUBJECT(S) PERSISTED. THE SAME DAY, THE CONSULTING PHYSICIAN CONTACTED THE TEST SUBJECT AND DISCUSSED THE COMPLAINT OF UNILATERAL EXTERNAL JAW PAIN AT THE SITE OF CONTACT FOR THE COLLECTION DEVICE. THE TEST SUBJECT DID NOT HAVE INTRA ORAL PAIN OR LESIONS. THE CONSULTING PHYSICIAN CONCLUDED THAT THE TEST SUBJECT(S) PAIN WAS UNLIKELY TO BE DUE TO THE COLLECITON DEVICE.