ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Received Oct 13, 2000 · Event occurred Sep 10, 2000
Report 3023752-2000-00029 · MDR key 300125
Device
Generic name
Oral Fluid Collection Device
Manufacturer
Epitope, Inc.Model number
503-0011Catalog number
NA
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
41 YR
- Urticaria
- Treatment with medication(s)
Narrative
Description of Event or Problem
PT WITH NO HISTORY OF URTICARIA WHO DEVELOPED SAME ABOUT ONE HOUR AFTER PROVIDING AN ORAL FLUID SAMPLE WITH THE ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE. TEST SUBJECT IS ALLERGIC TO MILK AND PEANUT BUTTER (NO RECENT EXPOSURE TO THOSE FOODS). THE TEST SUBJECT WAS ON THE MEDICATIONS RISPERDAL, WELLBUTRIN, AND REMERON AT THE TIME OF THE INCIDENT. THE TEST SUBJECT HAD BEEN ON THE MEDICATIONS FOR THREE WEEKS PRIOR TO THE INCIDENT WITHOUT EVIDENCE OF ALLERGIC PHENOMENA. THE URTICARIAL EPISODES BECAME RECURRENT OVER A 4 DAY PERIOD AND IMPROVED WITH BENADRYL, EPINEPHRINE, AND REDUCED STIMULATION. THE EPISODES RESOLVED WITH ZYRTEC AND THE DISCONTINUATION OF THE WELLBUTRIN. ACCORDING TO THE TEST SUBJECT'S PHYSICIAN, THE URTICARIA WAS EXACERBATED BY EMOTIONAL STRESS. THE TEST SUBJECT'S PHYSICIAN DID NOT PROVIDE CO WITH THE ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE LOT NUMBER. A LIST OF THE INGREDIENTS FOR THE DEVICE WAS FAXED TO THE PHYSICIAN.