FDA Adverse Event
Injury
Summary report: N
NARVAL CC ORTHESE MRD
MDR report key: 4039893
·
Received July 30, 2014
Report
- Report Number
- 3007573469-2014-00007
- Event Type
- Injury
- Date Received
- July 30, 2014
- Date of Event
- July 1, 2014
- Report Date
- July 30, 2014
- Manufacturer
- RESMED SAS
- Product Code
- LQZ
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO RESMED RMT THAT THE NARVAL CC MANDIBULAR REPOSITIONING DEVICE CONTRIBUTED TO A TOOTH LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 445883 | NARVAL CC ORTHESE MRD | LQZ | RESMED SAS | 200002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |