ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Received May 17, 2000 · Event occurred Dec 4, 1999
Report 3023752-2000-00024 · MDR key 278615
Device
Generic name
Oral 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
- Allergic reaction
- Headache
- Itching Sensation
- Swelling
- Dizziness
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
THE COMPLAINANT REPORTED THAT ON 12/2/1999, COMPLAINANT GAVE AN ORAL FLUID SPECIMEN USING THE ORASURE COLLECTION DEVICE FOR INSURANCE PURPOSES. COMPLAINANT REPORTED SWELLING OF THE JAW, ITCHINESS, SWOLLEN EYE LIDS, AND DIZZINESS. IN ADDITION, COMPLAINANT REPORTED THAT THEIR LIPS WERE DRY AND CRACKING BUT WAS UNSURE IF THAT WAS WEATHER RELATED OR DUE TO THE USE OF THE DEVICE. THE PHYSICIAN CONSULATANT CONTACTED THE COMPLAINANT AN LEARNED THAT THE SYMPTOMS RESOLVED WITHIN APPROXIMATELY 48 HOURS. COMPLAINANT REPORTED TO PHYSICIAN THAT THEY HAD NOTICED BILATERAL EYELID SWELLING, HEADACHE, AND A SORE JAW. COMPLAINANT REPORTED THAT THERE WERE NO MUCOSAL LESIONS.