MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-06 for RELIEVA STRATUS MICROFLOW SPACER BC1417RS manufactured by Acclarent Inc.
[2796312]
The surgeon reported that in reviewing the ct scan of the patient, she found the patient had acclarent stratus spacer implanted in the frontal recess for an unknown duration. The surgeon decided to dissect and remove the stratus. Acclarent was informed that the patient is doing well reported did well and no additional care was required.
Patient Sequence No: 1, Text Type: D, B5
[10029478]
Acclarent followed up on this report to gather additional information. The referring physician did not recall placing the stratus and the patient and his family were not told the stratus implant was used. The implanted stratus spacer was removed successfully and the device was intact. The acclarent stratus devices are approved for implantation for a 14 days period. While the acclarent stratus device was left in place far beyond the 14 days indication, there was no injury to the patient and no additional care because of retained stratus device. The subject device of this report was not returned for evaluation, and its whereabouts are unknown. No other devices were returned for evaluation from the user facility. 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 | 3005172759-2012-00028 |
| MDR Report Key | 2703747 |
| Report Source | 05 |
| Date Received | 2012-08-06 |
| Date of Report | 2012-07-17 |
| Date of Event | 2012-07-16 |
| Date Mfgr Received | 2012-07-17 |
| Date Added to Maude | 2012-08-24 |
| 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 |
| Manufacturer Contact | NOOSHIN ASBAGH, DIRECTOR |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506875398 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA STRATUS MICROFLOW SPACER |
| Generic Name | STRATUS FRONTAL SPACER |
| Product Code | KAM |
| Date Received | 2012-08-06 |
| Model Number | BC1417RS |
| Catalog Number | BC1417RS |
| 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 | 1. Required No Informationntervention | 2012-08-06 |