MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-12 for ENCORE SYSTEM FG0002 manufactured by Siesta Medical Inc..
[5949206]
Physician reported that a patient treated with hyoid suspension had developed a wound infection. The physician stated that he made a "few efforts" to drain and debride the infection but it persisted. The persistent infection led to the surgical removal of the encore sutures and bone anchors. The device was implanted approximately (b)(6) 2015. The physician reported that the infection appeared to be in soft tissue and followed the suture path from mandible to hyoid bone.
Patient Sequence No: 1, Text Type: D, B5
[13446419]
The device was not returned to the manufacturer for evaluation and multiple unsuccessful attempts have been made to get additional information from the surgeon, therefore, we are unable to determine the definitive cause of the event. Although it is unknown 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 additional information be obtained, a supplemental 3500a form will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008792120-2015-00001 |
| MDR Report Key | 4770901 |
| Report Source | 05 |
| Date Received | 2015-05-12 |
| Date of Report | 2015-05-12 |
| Date of Event | 2015-04-13 |
| Date Mfgr Received | 2015-04-13 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-05-15 |
| 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, STE 3 |
| Manufacturer City | LOS GATOS CA 95030 |
| Manufacturer Country | US |
| Manufacturer Postal | 95030 |
| Manufacturer Phone | 4083209424 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENCORE SYSTEM |
| Generic Name | TONGUE/HYOID SUSPENSION SYSTEM |
| Product Code | ORY |
| Date Received | 2015-05-12 |
| Model Number | FG0002 |
| Catalog Number | FG0002 |
| Lot Number | 523074A |
| Device Expiration Date | 2016-08-01 |
| 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 | 2015-05-12 |