OtherLIO
ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Received May 17, 2000 · Event occurred Jul 1, 1999
Report 3023752-2000-00022 · MDR key 278386
Device
Generic name
Oral Fluid Specimen Collection Device
Manufacturer
Epitope, Inc.Model number
503-0011Catalog number
NA
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Pain
- Ulceration
- Ulcer
Narrative
Description of Event or Problem
ON 10/25/99, A PT PRESENTED TO THE CLINIC AND REPORTED THAT PT HAD A SMALL NON-PAINFUL ULCER IN THE MOLAR REGION OF PT'S GUMS AND QUESTIONED WHETHER THE ORASURE COLLECTION COULD HAVE CAUSED THIS. THE PT HAD COLLECTED AN ORAL FLUID SPECIMEN WITH THE DEVICE APPROX THREE MONTHS BEFORE AND NOTED THAT THE ULCER APPEARED SHORTLY AFTER USING THE DEVICE. THE ULCER HAD BEEN PRESENT SINCE THAT TIME.