MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-07-02 for RELIEVA STRATUS MIRCOFLOW SPACER BC1417RS manufactured by Acclarent, Inc..
[2828686]
The physician reported that the pt felt that she swallowed one of the stratus devices that dislodged due to sneezing. The physician confirmed that the ethmoid spacer was dislodged since he could only see one device. The physician also confirmed that there was no airway issue other than pt's usual asthma. On (b)(6) 2011, the other spacer had been removed. The pt continues to have no effect from the potential swallowed stratus spacer 16 days after the event.
Patient Sequence No: 1, Text Type: D, B5
[10093696]
The surgeon stated all acclarent devices functioned as intended. The surgeon suggested that as the steroids within the stratus eluted, the polyps resolved and the spacer came loose. The physician did not feel that the asthma is in anyway related to the procedure or swallowed stratus. The vp of medical affairs stated that there wasn't any adverse event from the swallowed implant. The device in the reported event was not returned for eval and its whereabouts is unk. Production records were reviewed and no deviations were noted that would likely cause or contribute to the reported event. 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 | 3005172759-2012-00024 |
| MDR Report Key | 2652462 |
| Report Source | 05,07 |
| Date Received | 2012-07-02 |
| Date of Report | 2011-02-14 |
| Date of Event | 2011-02-05 |
| Date Mfgr Received | 2011-02-14 |
| 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 | BC1417RS |
| Catalog Number | BC1417RS |
| Lot Number | 100426C/101013A |
| 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 |