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OtherLIO

ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

Received May 17, 2000 · Event occurred Jan 31, 1999

Report 3023752-2000-00018 · MDR key 278533

Device

Generic name

Oral Fluid Specimen Collection

Manufacturer

Epitope, Inc.

Model number

503-0011

Catalog number

NA

Lot number

UNK

Product problems

  • Unknown (for use when the device problem is not known)

Patient

UNKNOWN

  • Soreness

Narrative

Description of Event or Problem

ON 1/31/1999 THE COMPLAINANT PROVIDED AN ORAL FLUID SPECIMEN USING AN ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE. COMPLAINANT EXPERIENCED SORE GUMS AND A TENDER GUMLINE.