MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-17 for WINX SLEEP THERAPY SYSTEM 11812 * manufactured by Apnicure Inc..
[19569694]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3641098 |
| MDR Report Key | 3641098 |
| Date Received | 2014-01-17 |
| Date of Report | 2014-01-14 |
| Date of Event | 2013-12-01 |
| Report Date | 2014-01-14 |
| Date Reported to FDA | 2014-01-17 |
| Date Reported to Mfgr | 2014-02-24 |
| Date Added to Maude | 2014-02-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WINX SLEEP THERAPY SYSTEM |
| Generic Name | INTRAORAL PRESSURE GRADIENT DEVICE |
| Product Code | OZR |
| Date Received | 2014-01-17 |
| Model Number | 11812 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APNICURE INC. |
| Manufacturer Address | 900 CHESAPEAKE DRIVE REDWOOD CITY CA 94063 US 94063 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-17 |