EPISCREEN ORAL SPECIMEN COLLECTION DEVICE

Description of Event or Problem

ON APPROX 6/18/1997, A COMPLAINANT EXPERIENCED SMALL BLOOD BLISTERS ON THE INSIDE OF THE MOUTH AFTER COLLECTION OF AN ORAL FLUID SPECIMEN IN SUPPORT OF A DISABILITY INSURANCE CLAIM. THE COMPLAINANT HAD COLLECTED THE SPECIMEN USING THE EPISCREEN HIV-1 ORAL SPECIMEN COLLECTION DEVICE. COMPLAINANT REPORTED THAT THE INSURANCE AGENT CONDUCTING THE SPECIMEN COLLECTION HAD ASKED COMPLAINANT TO RUB THE PAD BRISKLY BACK AND FORTH ALONG COMPLAINANT'S LOWER GUM LINE. THE COMPLAINANT REQUESTED A LIST OF THE INGREDIENTS OF THE COLLECTION PAD IN CASE COMPLAINANT WAS ALLERGIC TO ANY OF THEM. AT THE TIME OF THE INITIAL REPORT TO THE MFR, THE COMPLAINANT REPORTED THAT THE BLISTERS WERE PRACTICALLY GONE.