inforMED
OtherLIO

ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

Received May 17, 2000 · Event occurred Feb 9, 2000

Report 3023752-2000-00005 · MDR key 278857

Device

Generic name

Oral Fluid Specimen Collection

Manufacturer

Epitope, Inc.

Model number

503-0011

Catalog number

NA

Lot number

UNK

Product problems

  • Other (for use when an appropriate device code cannot be identified)

Patient

UNKNOWN

  • Exposure to Body Fluids

Narrative

Description of Event or Problem

THE COMPLAINANT, AN INSURANCE AGENT, REPORTED AN ACCIDENTAL EXPOSURE TO BODY FLUIDS AFTER COMPLETION OF AN ORAL FLUID COLLECTION USING AN ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE. PRIOR TO CONDUCTING AN ORAL FLUID COLLECTION FROM THE PROPOSED INSURED, THE COMPLAINANT FELL DOWN AND SUFFERED AN ABRASION BELOW THE LITTLE FINGER. THE COMPLAINANT REPORTS THAT THERE WAS SOME SLIGHTLY BROKEN SKIN AT THE ABRASION SITE. FOLLOWING ADMINISTRATION OF THE ORAL FLUID COLLECTION, THE COMPLAINANT CLEANED UP THE WRAPPERS, INSTRUCTIONS, AND THE DISCARDED STICK HANDLES OF THE DEVICE. WHILE CLEANING UP THESE ITEMS, THE COMPLAINANT'S LEFT HAND CAME INTO CONTACT WITH THE DISCARDED STICK OF THE PROPOSED INSURED. THE STICK WAS WET WITH WHAT THE COMPLAINANT PRESUMES TO BE THE PROPOSED INSURED'S SALIVA. THE STICK CAME INTO CONTACT WITH THE COMPLAINANT'S ABRASION AND BROKEN SKIN. THE COMPLAINANT WAITED TO WASH THE HANDS UNTIL CONPLAINANT ARRIVED AT HOME BECAUSE THE BATHROOM AT THE PROPOSED INSURED WAS OCCUPIED AT THE TIME OF THE ACCIDENTAL EXPOSURE. THE COMPLAINANT EXPRESSED CONCERN THAT COMPLAINANT HAD BEEN EXPOSED TO SOMETHING THROUGH CONTACT WITH THE DISCARDED STICK AND LATER LEARNED THAT THE PROPOSED INSURED HAD BEEN DENIED INSURANCE COVERAGE.