FDA Adverse Event
Injury
Summary report: N
ENCORE SYSTEM
MDR report key: 20153491
·
Received September 5, 2024
Report
- Report Number
- 3008792120-2024-00008
- Event Type
- Injury
- Date Received
- September 5, 2024
- Report Date
- November 7, 2024
- Manufacturer
- SIESTA MEDICAL, INC.
- Product Code
- ORY
- PMA / PMN Number
- K213159
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE PATIENT HAD A SUCCESSFUL HYOID SUSPENSION AND RECOVERY. AT SOME POINT AFTERWARD, THE PATIENT SNEEZED AND FELT A "POP' " IN THE LOCATION OF THE HYOID SUSPENSION AND FELT IMMEDIATE PAIN IN THAT AREA. THE PATIENT WENT TO THE ER AND THE STAFF DIAGNOSED A FRACTURED HYOID BONE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Description of Event or Problem · 0
THE PATIENT HAD A SUCCESSFUL HYOID SUSPENSION AND RECOVERY. AT SOME POINT AFTERWARD, THE PATIENT SNEEZED AND FELT A "POP' " IN THE LOCATION OF THE HYOID SUSPENSION AND FELT IMMEDIATE PAIN IN THAT AREA. THE PATIENT WENT TO THE ER AND THE STAFF DIAGNOSED A FRACTURED HYOID BONE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2140290 | ENCORE SYSTEM | INTRAORAL DEVICE FOR SNORING AND SLEEP APNEA | ORY | SIESTA MEDICAL, INC. | FG0002 | 1147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |