OtherLIO
ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Received May 17, 2000 · Event occurred Dec 1, 1999
Report 3023752-2000-00025 · MDR key 278634
Device
Generic name
Oral Fluid Specimen Collection Device
Manufacturer
Epitope, Inc.Model number
503-0011Catalog number
NA
Lot number
NUNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Allergic reaction
Narrative
Description of Event or Problem
THE COMPLAINANT REPORTED ON 12/21/1999, BY VOICE MAIL, THAT THEY BELIEVED THEY WERE HAVING AN ALLERGIC REACTION TO THE ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE. NO FURTHER INFORMATION WAS OBTAINED FROM THE COMPLAINANT AS COMPLAINANT DID NOT RESPOND TO ATTEMPTS TO FOLLOW-UP ON THE ADVERSE EVENT.