inforMED
InjuryLIO

KIT,APTIMA CMB2 SWAB SPEC COLL 50PK CE

Received Aug 22, 2018 · Event occurred Jul 30, 2018

Report 2024800-2018-00007 · MDR key 7806222

Device

Generic name

In-vitro Diagnostic

Manufacturer

Hologic, Inc.

Catalog number

301041-01

Product problems

  • Device Handling Problem
  • Device Handling Problem

Patient

Not reported

  • Injury
  • Injury

Narrative

Description of Event or Problem

CUSTOMER, (B)(6), REPORTED AN INCIDENT WHERE A CHILD INGESTED AN UNKNOWN VOLUME OF APTIMA TRANSPORT MEDIA, PRIOR TO COLLECTION OF SAMPLE. THE SWAB COLLECTION TUBE CONTAINS SOLN., TRANSPORT MEDIA (PN: 101768). THE CHILD WAS GIVEN PLENTY OF WATER TO DRINK AS TREATMENT. PER THE SAFETY DATA SHEET FOR TRANSPORT MEDIA/COLLECTION DEVICES (REV. DATE 06/25/2018), THE FIRST AID MEASURE FOR INGESTION IS TO "CLEAN MOUTH WITH WATER AND DRINK AFTERWARDS PLENTY OF WATER. IF SYMPTOMS PERSIST, CALL A PHYSICIAN". IN ADDITION, THE PRODUCT CONTAINS NO SUBSTANCES, WHICH AT THEIR GIVEN CONCENTRATION, ARE CONSIDERED TO BE HAZARDOUS TO HEALTH. CUSTOMER HAS NOT CALLED BACK FOR ANY OTHER ISSUES.