MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-30 for NARVAL CC ORTHESE MRD manufactured by Resmed Sas.
[4801078]
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
[12277745]
The dentist returned the device and the original models of the pt's teeth. The returned device fit the original teeth model that was used to fabricate the device. The info provided by the reporter indicates that the pt had an existing dental condition. This condition may have been exacerbated by the use of the mandibular device and led to the pt's tooth removal.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004604967-2014-00018 |
| MDR Report Key | 4039863 |
| Report Source | 05 |
| Date Received | 2014-07-30 |
| Date Mfgr Received | 2014-07-02 |
| Device Manufacturer Date | 2013-12-06 |
| Date Added to Maude | 2014-08-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID DULEY, ENGINEER |
| Manufacturer Street | 9001 SPECTRUM CENTER BLVD |
| Manufacturer City | SAN DIEGO CA 92123 |
| Manufacturer Country | US |
| Manufacturer Postal | 92123 |
| Manufacturer Phone | 8588365985 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NARVAL CC ORTHESE MRD |
| Product Code | LQZ |
| Date Received | 2014-07-30 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-07-30 |