MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-24 for ENCORE SYSTEM FG0002 manufactured by Siesta Medical, Inc..
[176381810]
On (b)(6) 2019 the physician reported that a patient who underwent hyoid suspension and tongue suspension on (b)(6) 2019 had discomfort he was not satisfied with the changes in his sleep apnea. The physician reported that the removal procedure was scheduled for (b)(6) 2019. The [physician later reported that the patient returned for a post-operative visit on (b)(6) 2019 and the patient was healing well and without pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008792120-2020-00001 |
| MDR Report Key | 9629365 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-22 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2020-01-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MICHAEL KOLBER |
| Manufacturer Street | 101 CHURCH STREET SUITE 3 |
| Manufacturer City | LOS GATOS CA 95030 |
| Manufacturer Country | US |
| Manufacturer Postal | 95030 |
| Manufacturer Phone | 4083209424 |
| Manufacturer G1 | SIESTA MEDICAL, INC. |
| Manufacturer Street | 101 CHURCH STREET SUITE 3 |
| Manufacturer City | LOS GATOS CA 95030 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENCORE SYSTEM |
| Generic Name | TONGUE/HYOID SUSPENSION |
| Product Code | ORY |
| Date Received | 2020-01-24 |
| Model Number | FG0002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIESTA MEDICAL, INC. |
| Manufacturer Address | 101 CHURCH STREET SUITE 3 LOS GATOS CA 95030 US 95030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-24 |