FDA Adverse Event
Malfunction
Summary report: N
ENCORE SYSTEM
MDR report key: 17730359
·
Received September 12, 2023
Report
- Report Number
- 3008792120-2023-00020
- Event Type
- Malfunction
- Date Received
- September 12, 2023
- Date of Event
- August 1, 2023
- Report Date
- September 11, 2023
- Manufacturer
- SIESTA MEDICAL, INC.
- Product Code
- ORY
- PMA / PMN Number
- K201238
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
PATIENT REPORTED THAT HE SUSPECTED THE SUTURE BROKE. HE IS SCHEDULED TO MEET WITH THE PHYSICIAN FOR AN EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1145353 | ENCORE SYSTEM | INTRAORAL DEVICE FOR SNORING AND OBSTRUCTIVE SLEEP APNEA | ORY | SIESTA MEDICAL, INC. | FG0002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Other |