MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-30 for NARVAL CC ORTHESE MRD 200002 manufactured by Resmed Sas.
[16182242]
It was reported to resmed rmt that the narval cc mandibular repositioning device contributed to a tooth loss.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007573469-2014-00007 |
| MDR Report Key | 4039893 |
| Date Received | 2014-07-30 |
| Date of Report | 2014-07-30 |
| Date of Event | 2014-07-01 |
| Date Facility Aware | 2014-07-02 |
| Date Added to Maude | 2014-08-28 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 9001 SPECTRUM CENTER BOULEVARD -- |
| Manufacturer City | SAN DIEGO CA 921230000 |
| Manufacturer Country | US |
| Manufacturer Postal | 921230000 |
| Manufacturer G1 | RESMED CORP |
| Manufacturer Street | 9001 SPECTRUM CENTER BOULEVARD -- |
| Manufacturer City | SAN DIEGO CA 92123000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92123 0000 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NARVAL CC ORTHESE MRD |
| Product Code | LQZ |
| Date Received | 2014-07-30 |
| Returned To Mfg | 2014-07-09 |
| Model Number | 200002 |
| Catalog Number | 200002 |
| ID Number | PR763228 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 7 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED SAS |
| Manufacturer Address | 292 ALLEE JACQUES MONOD DENTAL SLEEP BUSINESS, PARC TECHNOLOGIQUE DE LYON SAINT PRIEST CEDEX 69791 FR 69791 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2014-07-30 |