OtherLIO
EPISCREEN HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Received May 17, 2000 · Event occurred May 1, 1998
Report 3023752-2000-00010 · MDR key 278396
Device
Generic name
Oral Fluid Specimen Collection
Manufacturer
Epitope, Inc.Model number
NACatalog number
NA
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Blister(s)
- Itching Sensation
- Other (for use when an appropriate patient code cannot be identified)
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
ON 5/1/98 THE COMPLAINANT PROVIDED AN ORAL FLUID SPECIMEN USING THE EPISCREEN HIV-1 ORAL SPECIMEN COLLECTION DEVICE. COMPLAINANT BROKE OUT WITH ITCHING, AND BUMPS AND BLISTERS ON THE ARMS AND LEGS IMMEDIATELY FOLLOWING THE COLLECTION PROCEDURE. COMPLAINANT CONTINUED TO HAVE BUMPS AND ITCHING OF THE ARMS THREE DAYS LATER. THE COMPLAINANT REPORTED TO EPITOPE'S PHYSICIAN CONSULTANT THAT COMPLAINANT HAD NO ADD'L SYSTEMIC COMPLAINTS.