RELIEVA FLEX SINUS GUIDE CATHETER
Received Apr 11, 2016 · Event occurred Mar 18, 2016
Report 3005172759-2016-00008 · MDR key 5568783
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
(B)(4). THE LOT HISTORY RECORD(S) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE LHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).
Description of Event or Problem
ACCLARENT WAS INFORMED OF AN EVENT WHICH OCCURRED RIGHT AFTER THE RIGHT MAXILLARY SINUS PROCEDURE ON (B)(6) 2016, IN WHICH A RELIEVA FLEX SINUS GUIDE CATHETER WAS USE. THE PATIENT RETURNED TO THE OFFICE WITH A MINOR REACTION. THE PATIENT'S RIGHT EYE WAS COMPLETELY CLOSED AND THE PATIENT COULD NOT OPEN IT. THE PHYSICIAN CONSULTED WITH THE OPHTHALMOLOGIST WHO WAS NOT CLEAR ABOUT THE REACTION. THE PATIENT RETURNED TO THE OFFICE TO HAVE THE PHYSICIAN EXAMINE THE EYE. THERE WAS NO VISUAL CHANGE REPORTED AND THE PATIENT DID NOT EXPERIENCE PAIN. THE PATIENT WAS PRESCRIBED ORAL STEROID AND IS REPORTED TO BE WELL AND HAS BEEN DOING WELL.