ORASURE HIV-1 ORAL SPECIMEN COLLECITON DEVICE
Received May 25, 2001 · Event occurred Apr 27, 2001
Report 3023752-2001-00007 · MDR key 335053
Device
Generic name
Oral Fluid Collection Device
Manufacturer
Orasure TechnologiesModel number
503-0011Catalog number
NA
Lot number
K341
Product problems
- Reaction
Patient
NO INFO
- Burning Sensation
Narrative
Description of Event or Problem
TEST SUBJECT REPORTED A BURNING SENSATION IN THE MOUTH THREE DAYS AFTER PROVIDING AN ORAL FLUID SAMPLE WITH THE ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE. THE TEST SUBJECT ANONYMOUSLY PROVIDED THE SAMPLE AND DID NOT PROVIDE THEIR NAME TO THE COUNSELOR WHEN REPORTING THE COMPLAINT. THE USER FACILITY HAS NOT REPLIED TO THE MANUFACTURER'S REQUESTS FOR MORE INFO.