EPISCREEN HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Received May 17, 2000 · Event occurred Oct 1, 1998
Report 3023752-2000-00015 · MDR key 278498
Device
Generic name
Oral Fluid Specimen Collection
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
- Erythema
- Irritation
- Swelling
Narrative
Description of Event or Problem
AN INSURANCE CLIENT REPORTED THAT SWELLING, REDNESS, AND IRRITATION OF THEIR GUMS IN THE LOCATION WHERE THE COLLECTION PAD HAD BEEN PLACED FOLLOWING ORAL FLUID SPECIMEN COLLECTION. THE CLIENT REPORTED THE ADVERSE EVENT THE DAY AFTER THE COLLECTION PROCEDURE TOOK PLACE. THE INSURANCE AGENCY UNDERWRITER, CONFIRMED THAT THE PROCEDURE HAD BEEN PERFORMED CORRECTLY. THE INSURANCE COMPANY WAS GIVEN A COPY OF THE MSDS AND LIST OF COLLECTION PAD INGREDIENTS. NO FURTHER CONTACTS WERE MADE FROM THE CLIENT TO THE INSURANCE AGENCY REGARDING THE INCIDENT.