RELIEVA LUMA SENTRY SINUS ILLUMINATION SYSTEM
Received Aug 21, 2014 · Event occurred Aug 1, 2012
Report 3005172759-2014-00021 · MDR key 4093141
Product problems
- Unsealed Device Packaging
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE USER REPORTED HAVING RECEIVED THE SUBJECT DEVICE IN AN OPEN POUCH. ALL OTHER DEVICES WITHIN THE SAME BOX WERE EXAMINED AND CONFIRMED TO BE SEALED. A DEVICE FROM A SEALED POUCH WAS USED TO PERFORM THE PROCEDURE. THE PHENOMENON WAS DISCOVERED BEFORE USE, AND THERE WAS NO ADVERSE IMPACT TO THE PATIENT REPORTED.
Additional Manufacturer Narrative
THE DEVICE, WITH ITS ORIGINAL PACKAGING, WAS RECEIVED AND EVALUATED. ACCLARENT CONFIRMED THAT NO SEAL WAS PRESENT AT THE BOTTOM EDGE OF THE RETURNED POUCH. ACCLARENT HAS TAKEN STEPS TO REDUCE THE LIKELIHOOD OF RECURRENCE, AND WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.