MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-06-02 for NARVAL CC ORTHESE MRD 200002 manufactured by Resmed Sas.
[46463382]
The device has not been returned to the manufacturer, therefore, resmed is unable to determine if a device fault contributed to the incident. Resmed is in communication with the reporter to obtain additional information regarding the event details and requested the unit be returned so that an extensive engineering investigation can be performed. Resmed reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[46463383]
It was reported to resmed (b)(4) that a narval cc mandibular repositioning device fractured a patient's lower anterior tooth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004604967-2016-00580 |
| MDR Report Key | 5695963 |
| Report Source | USER FACILITY |
| Date Received | 2016-06-02 |
| Date of Report | 2016-06-02 |
| Date of Event | 2016-05-05 |
| Date Facility Aware | 2016-05-06 |
| Date Mfgr Received | 2016-05-06 |
| Device Manufacturer Date | 2016-04-06 |
| Date Added to Maude | 2016-06-02 |
| 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 | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID DULEY |
| 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 |
| Generic Name | DEVICE, JAW REPOSITIONING |
| Product Code | LQZ |
| Date Received | 2016-06-02 |
| Model Number | 200002 |
| Catalog Number | 200002 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED SAS |
| Manufacturer Address | PARC TECHNOLOGIQUE DE LYON 292 ALLEE JACQUES MONOD SAINT PRIEST CEDEX, 69791 FR 69791 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-06-02 |