MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-12 for NARVAL manufactured by Resmed.
[49769667]
The narval sleep apnea device owned by (b)(4), isn't firm enough to keep it from putting pressure on your teeth like a orthodontic retainer. My teeth have shifted and i can no longer chew or close my teeth. (b)(4) has not offered me any solutions, despite having a three year warranty. I have no idea how i'm going to get my bite, probably will need to see an orthodontist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063436 |
| MDR Report Key | 5797975 |
| Date Received | 2016-07-12 |
| Date Added to Maude | 2016-07-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NARVAL |
| Generic Name | NARVAL |
| Product Code | LQZ |
| Date Received | 2016-07-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2016-07-12 |