ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Received May 17, 2000 · Event occurred Jan 1, 1999
Report 3023752-2000-00017 · MDR key 278402
Device
Generic name
Oral Fluid Specimen Collection
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
- Blister(s)
- Ulceration
- Other (for use when an appropriate patient code cannot be identified)
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
THE COMPLAINANT HAD AN ORASURE COLLECTION DEVICE PLACED IN THE BUCCAL MUCOSA AS PART OF AN INSURANCE EXAMINATION. ON THE EVENING FOLLOWING THE ORASURE DEVICE COLLECTION, THE COMPLAINANT DEVELOPED A BLISTER. THE FOLLOWING DAY, THE COMPLAINANT DEVELOPED ULCERS AROUND THE BLISTER AND COUNTED APPROX 7 TO 8 OF THESE. OVER THE ENSUING DAYS, THE ULCERS APPARENTLY RESOLVED BUT THE COMPLAINANT REPORTED THAT THE BLISTER PERSISTED. ADDITIONALLY, THE COMPLAINANT NOTED A DECREASE IN THE SENSE OF TASTE. COMPLAINANT SOUGHT FOLLOW-UP CARE FROM AN OTOLARYNGOLOGIST.