RELIEVA STRATUS MIRCOFLOW SPACER
Received Jul 2, 2012 · Event occurred Jan 6, 2010
Report 3005172759-2012-00023 · MDR key 2652464
Device
Generic name
Stratus Ethmoid Spacer
Manufacturer
Acclarent, Inc.Model number
BC1017RSCatalog number
BC1017RS
Lot number
UNK
Product problems
- Device Operates Differently Than Expected
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THERE WAS NO INJURY TO THE PT. THE DEVICE IN REPORTED EVENT WAS NOT RETURNED FOR EVAL. DUE TO LACK OF PHYSICIAN'S RESPONSE TO OUR REQUEST, NO ADD'L DETAILS ARE AVAILABLE. IT WAS SUSPECTED THAT EITHER IMPROPER PLACEMENT, IMPROPER IRRIGATION, OR UNIQUE PT ANATOMY CONTRIBUTED TO THE DISLODGMENT OF THE DEVICE. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.
Description of Event or Problem
THE PHYSICIAN REPORTED THAT PT HAD SNEEZED OUT AN ETHMOID IMPLANTED STRATUS. FURTHER QUESTION REGARDING HOSPITALIZATION/INJURY/DEVICE DETAILS WERE REQUESTED ON (B)(6) 2010 BUT NO FURTHER INFO WAS PROVIDED.
Remedial action
- Other