InjuryMKZ
COBAS® PCR MEDIA DUAL SWAB SAMPLE KIT
Received Jun 25, 2020 · Event occurred Jun 8, 2020
Report 2243471-2020-00012 · MDR key 10195177
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Product code (MKZ)
Manufacturer (Roche Molecular Systems, Inc.)
Model (NA)
Device
Generic name
Specimen Collection Kit
Manufacturer
Roche Molecular Systems, Inc.Model number
NACatalog number
07958021190
Lot number
F30987
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THROUGH THE COURSE OF THE INVESTIGATION, WHICH INCLUDED A VISUAL INSPECTION OF THE RETAIN COMPLAINT KIT LOT AND REVIEW OF THE INSTRUCTIONS FOR USE (ENGLISH AND (B)(6) TRANSLATION), NO PRODUCT PROBLEM WAS IDENTIFIED. (B)(4).
Description of Event or Problem
A (B)(6) CUSTOMER REPORTED THAT A PATIENT SWALLOWED A PIECE OF THE COBAS® PCR MEDIA DUAL SWAB DURING OROPHARYNGEAL SPECIMEN COLLECTION, AND NEEDED TO BE TAKEN TO THE EMERGENCY ROOM. NO FURTHER PATIENT DETAILS WERE PROVIDED.