MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-25 for ENSORE SYSTEM FG0002 manufactured by Siesta Medical Inc..
[4866448]
Physician reported that a pt treated with tongue suspension had developed a wound infection which was treated by irrigation, drainage and oral antibiotics which did not resolve. The persistent infection lead to the removal of the encore bone anchors and suture. Infection resolution approx was reported post device removal. The physician noted the infection appeared to be a "regular" wound infection and did not suspect specific device involvement.
Patient Sequence No: 1, Text Type: D, B5
[11922072]
The device was not returned to the mfr for eval, therefore we are unable to determine the definitive cause of the event. Although it is unk if the device contributed to the reported event, this mdr is being filed for notification purposes. No conclusion can be drawn at this time. Should add'l info be obtained, a supplemental 3500a form will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008792120-2014-00001 |
| MDR Report Key | 4060317 |
| Report Source | 05 |
| Date Received | 2014-08-25 |
| Date of Report | 2014-08-18 |
| Date of Event | 2014-07-31 |
| Date Mfgr Received | 2014-08-12 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2014-09-05 |
| 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 Street | 101 CHURCH ST |
| Manufacturer City | LOS GATOS CA 950300000 |
| Manufacturer Country | US |
| Manufacturer Postal | 950300000 |
| Manufacturer Phone | 4083209424 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENSORE SYSTEM |
| Generic Name | TONGUE/HYOID SUSPENSION SYSTEM |
| Product Code | ORY |
| Date Received | 2014-08-25 |
| Model Number | FG0002 |
| Catalog Number | FG0002 |
| Lot Number | 502044B |
| Device Expiration Date | 2016-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIESTA MEDICAL INC. |
| Manufacturer Address | LOS GATOS CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-25 |