OtherLIO
EPISCREEN HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Received May 17, 2000 · Event occurred Nov 18, 1998
Report 3023752-2000-00016 · MDR key 278555
Device
Generic name
Oral Fluid Specimen Collection Device
Manufacturer
Epitope, Inc.Model number
503-0031Catalog number
NA
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Allergic reaction
- Abdominal Cramps
Narrative
Description of Event or Problem
THE COMPLAINANT PROVIDED AN EPISCREEN ORAL FLUID SAMPLE DURING A LIFE INSURANCE EXAM. COMPLAINANT STARTED TO EXPERIENCE STOMACH CRAMPS APPROXIMATELY 15 MINUTES AFTER THE COLLECTION PROCEDURE. THE COMPLAINANT CALLED TO INQUIRE ABOUT THE INGREDIENTS OF THE DEVICE'S COLLECTION PAD AND IF THEY COULD INTERACT WITH ANTIBIOTICS.