FDA Adverse Event
Summary report: N
WINX SLEEP THERAPY SYSTEM
MDR report key: 3641098
·
Received January 17, 2014
Report
- Report Number
- 3641098
- Date Received
- January 17, 2014
- Date of Event
- December 1, 2013
- Report Date
- January 14, 2014
- Manufacturer
- APNICURE INC.
- Product Code
- OZR
- Report Source
- User Facility report
- Reporter Location
- MN, US
Narratives
Description of Event or Problem · 1
ON TWO SEPARATE SLEEP STUDY TRIALS UTILIZING TWO DIFFERENT SIZED MOUTH PIECES, THE PATIENT DEVELOPED SOFT PALATE PAIN, HEMATOMAS AND BLEEDING FOLLOWING THE USE OF THE WINX SLEEP THERAPY SYSTEM.MANUFACTURER RESPONSE FOR SLEEP THERAPY SYSTEM, WINX SLEEP THERAPY SYSTEM (PER SITE REPORTER).====================== THERE WAS NO RECORD OF THIS OCCURRING PREVIOUSLY. PATIENT CONDITION OR BLOOD THINNING MEDICATIONS COULD CONTRIBUTE TO BLEEDING. THEY HAVE NOTIFIED THEIR CHIEF ENGINEER AND WILL PLAN A SITE VISIT TO REVIEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46420 | WINX SLEEP THERAPY SYSTEM | INTRAORAL PRESSURE GRADIENT DEVICE | OZR | APNICURE INC. | 11812 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |