inforMED
OtherLIO

ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

Received Mar 6, 2001 · Event occurred Feb 14, 2001

Report 3023752-2001-00005 · MDR key 319345

Device

Generic name

Oral Fluid Collection

Model number

503-0011

Catalog number

NA

Lot number

K300

Product problems

  • Reaction

Patient

36 YR

  • Fall
  • Other (for use when an appropriate patient code cannot be identified)
  • Diaphoresis

Narrative

Description of Event or Problem

TEST SUBJECT PROVIDED COLLECTION WITH THE ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE FOR INSURANCE PURPOSES AT APPROX 3:30 PM IN 2001. THE PT IMMEDIATELY FELT HOT AND STARTED TO SWEAT. THE PT THOUGHT THEY WERE GOING TO PASS OUT. TEST SUBJECT WENT TO THE BATHROOM. NEXT THE PT PROCEEDED OUTSIDE AND FELL TO ONE KNEE. AFTER A FEW MINS THE PT SAT ON A BENCH OUTSIDE THE INSURANCE OFFICE. THE FAMILY MEMBER OF THE TEST SUBJECT REPORTED THE EVENT TO THE MFR. THE NEXT DAY, THE CO CONTACTED THE TEST SUBJECT AND THE PT STATED THAT THEY WERE FEELING BETTER. THE PT DID NOT WANT TO DISCUSS THE EVENT OR CONFER WITH THE CO'S CONSULTING PHYSICIAN REGARDING THE INGREDIENTS OF THE DEVICE OR THEIR REACTION. COLLECTION WAS PERFORMED ACCORDING TO THE PRODUCT INSERT. THE TEST SUBJECT IS NOT ALLERGIC TO GELATIN. GELATIN IS THE ONLY KNOWN INGREDIENT IN THE DEVICE THAT IS A POTENTIAL ALLERGEN.