inforMED
InjuryLSL

APTIMA VAGINAL SWAB COLLECTION KIT

Received May 20, 2016 · Event occurred May 3, 2016

Report 2024800-2016-00017 · MDR key 5669907

Device

Generic name

In-vitro Diagnostic Assay

Manufacturer

Hologic, Inc.

Catalog number

301162

Product problems

  • Improper or Incorrect Procedure or Method

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

FLUID FROM VAGINAL COLLECTION TUBE GOT INTO LABORATORY PERSONNEL'S EYE AFTER COLLECTING THE PATIENT COLLECTED SAMPLE. THE LAB WORKER FLUSHED THEIR EYE WITH WATER BEFORE VISITING DOCTOR. THE DOCTOR SAID THERE WAS NO DERMATITIS OR IRITIS OBSERVED. THE INJURED PERSON WAS NOT WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE INJURY.