inforMED
InjuryLSL

APTIMA UNISEX COLLECTION KIT

Received Jun 13, 2016 · Event occurred May 16, 2016

Report 2024800-2016-00018 · MDR key 5721294

Device

Generic name

In-vitro Diagnostic Assay

Manufacturer

Hologic, Inc.

Catalog number

301041-01

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Injury
  • Injury

Narrative

Description of Event or Problem

SOLUTION FROM APTIMA UNISEX COLLECTION KIT GOT INTO THE OPERATOR'S EYE. THE TUBE DID NOT CONTAIN A PATIENT SPECIMEN. THE OPERATOR WASHED HER EYE AT THE WASH STATION AND WAS TAKEN TO THE OCCUPATIONAL DOCTOR IN THE HOSPITAL. CUSTOMER REQUESTED A LIST OF CHEMICALS IN THE APTIMA UNISEX COLLECTION KIT SOLUTION, AND THE LIST FROM (B)(4) WAS PROVIDED.