MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-03 for ENCORE SYSTEM FG0002 manufactured by Siesta Medical Inc..
[4928345]
Physician reported that a patient treated with tongue suspension had developed an infection and subsequent granulation and sinus tract in the submental wound secondary to a hematoma. In (b)(6) 2013, the physician attempted to treat by irrigation and drainage. In (b)(6) 2013, the physician decided to remove the encore bone anchors and suture.
Patient Sequence No: 1, Text Type: D, B5
[12426048]
The device was not returned to the manufacturer for evaluation, 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 | 3008792120-2014-00004 |
| MDR Report Key | 4136193 |
| Report Source | 05 |
| Date Received | 2014-09-03 |
| Date of Report | 2014-09-02 |
| Date of Event | 2013-09-01 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2014-10-03 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 101 CHURCH ST SUITE 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/HYBRID SUSPENSION SYSTEM |
| Product Code | ORY |
| Date Received | 2014-09-03 |
| Model Number | FG0002 |
| Catalog Number | FG0002 |
| Lot Number | 513112C |
| Device Expiration Date | 2014-11-01 |
| 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 | 2014-09-03 |