MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-14 for ENCORE SYSTEM FG0002 manufactured by Siesta Medical Inc..
[130380755]
It does not appear that the device was the direct cause of the event as laryngospasm is a recognized risk from anesthesia. However, this event is being reported out of abundance of caution with respect to mdr requirements.
Patient Sequence No: 1, Text Type: N, H10
[130380756]
Physician reported that during recovery from anesthesia and after successful , routine hyoid suspension, the patient experienced a laryngeal spasm. The physician returned to the surgery center at which point the patient was not breathing. The physician performed an emergency tracheotomy and was able to re-establish breathing. However, the patient remained in a coma. As of (b)(6) 2018, the physician reported the patient was improving and was responding to verbal commands and can move all limbs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008792120-2018-00002 |
| MDR Report Key | 8165320 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-14 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-11-05 |
| Date Mfgr Received | 2018-11-19 |
| Date Added to Maude | 2018-12-14 |
| 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. TEDD HINTON |
| Manufacturer Street | 101 CHURCH STREET SUITE 3 |
| Manufacturer City | LOS GATOS CA 95030 |
| Manufacturer Country | US |
| Manufacturer Postal | 95030 |
| Manufacturer Phone | 4085963148 |
| 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 | 2018-12-14 |
| Model Number | FG0002 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2018-12-14 |