COBAS PCR MEDIA DUAL SWAB SAMPLE KIT
Received Aug 28, 2019 · Event occurred Aug 14, 2019
Report 2243471-2019-00034 · MDR key 8939410
Device
Generic name
Specimen Collection Kit
Manufacturer
Roche Molecular Systems, Inc.Model number
NACatalog number
07958021190
Lot number
NI
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
2 YR
- Complaint, Ill-Defined
- Complaint, Ill-Defined
Narrative
Additional Manufacturer Narrative
AS STATED IN THE COBAS PCR MEDIA DUAL SWAB SAMPLE KIT INSTRUCTIONS FOR USE, AVOID CONTACT OF THE COBAS PCR MEDIA WITH THE SKIN, EYES OR MUCOUS MEMBRANES. IF CONTACT DOES OCCUR, IMMEDIATELY WASH WITH LARGE AMOUNTS OF WATER. THE SAFETY DATA SHEET FOR THE MEDIA FURTHER STATES IT IS HARMFUL IF SWALLOWED. CLEAN MOUTH WITH WATER AND DRINK AFTERWARDS PLENTY OF WATER. KEEP RESPIRATORY TRACT CLEAR. NO HARM OR SERIOUS INJURY WAS ALLEGED, AND THE CHILD DID NOT SEEK ANY SPECIFIC MEDICAL ATTENTION. (B)(4).
Description of Event or Problem
A US CUSTOMER STATED THAT A (B)(6) YEAR CHILD MAY HAVE INGESTED A SMALL AMOUNT OF COBAS DUAL SWAB PCR MEDIA. POISON CONTROL CENTER WAS CONTACTED, AND THEY ADVISED TO TREAT AS AN IRRITANT. THE CHILD WAS NOT SEEN OR TREATED BY A MEDICAL PROFESSIONAL. THE CHILD WAS IN A STABLE CONDITION WITH NO CHANGE TO HEALTH. NO ADDITIONAL DETAILS WERE PROVIDED.