MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-07-02 for RELIEVA STRATUS MIRCOFLOW SPACER BC1017RS manufactured by Acclarent, Inc..
[20224136]
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.
Patient Sequence No: 1, Text Type: D, B5
[20597765]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2012-00023 |
| MDR Report Key | 2652464 |
| Report Source | 05 |
| Date Received | 2012-07-02 |
| Date of Report | 2010-01-07 |
| Date of Event | 2010-01-06 |
| Date Mfgr Received | 2010-01-07 |
| Date Added to Maude | 2012-10-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA STRATUS MIRCOFLOW SPACER |
| Generic Name | STRATUS ETHMOID SPACER |
| Product Code | KAM |
| Date Received | 2012-07-02 |
| Model Number | BC1017RS |
| Catalog Number | BC1017RS |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-02 |