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ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

Received May 17, 2000 · Event occurred Jul 22, 1999

Report 3023752-2000-00021 · MDR key 278630

Device

Generic name

Oral Fluid Specimen Collection Device

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

  • Rash

Narrative

Description of Event or Problem

A CLIENT OF THE COUNTY HEALTH DEPARTMENT REPORTED THAT TWO WEEKS AFTER CLIENTS ORASURE HIV-1 ORAL SPECIMEN COLLECTION, CLIENT HAS HAD THREE FACIAL RASHES BEGINNING TWO WEEKS AFTER THE TEST. THE CLIENT EXPRESSED THAT CLIENT WAS A VEGETARIAN AN WAS NOT INFORMED OF THE BOVINE GELATIN UNTIL AFTER TAKING THE TEST.