MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-10-31 for NARVAL CC ORTHESE MRD 200002 manufactured by Resmed Sas - Dental Sleep Business.
[15013201]
It was reported to resmed that a pt wearing a narval mandibular repositioning device (mrd) had significant teeth movement after three weeks of use.
Patient Sequence No: 1, Text Type: D, B5
[15459554]
The device has not been returned to resmed for investigation. However, the device was manufactured by resmed in accordance to the dentist's prescription. Based on the info provided by the dentist, this pt had previous orthodontic work and was using another mrd device for 8 yrs prior to using the narval device. It is unk if the previous device loaded or applied pressure to the incisors. The design of the narval device does not traditionally load the incisors. It is designed to rest on the most solid teeth (the upper maxilla at the canines and on the mandibular molars). The design also advances the mandible as parallel as possible to the pt's occlusal plane, thereby reducing local forces and pressure on individual teeth or dental segments, thereby limiting the risk of movement. Furthermore, the prescribing dentist is able to easily control and modify the degree of mandibular advancement which can also reduce the forces directed to the teeth. Narval instructions include a warning statement that "use of the device may cause: tooth movement or changes in dental occlusion. " the pt is currently on therapy and using his former device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004604967-2012-00042 |
| MDR Report Key | 2858160 |
| Report Source | 04 |
| Date Received | 2012-10-31 |
| Date of Report | 2012-10-31 |
| Date of Event | 2012-09-01 |
| Date Mfgr Received | 2012-09-09 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2012-12-21 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID DULEY, QUALITY ENGINEER |
| Manufacturer Street | 9001 SPECTRUM CENTER BLVD |
| Manufacturer City | SAN DIEGO CA 92123 |
| Manufacturer Country | US |
| Manufacturer Postal | 92123 |
| Manufacturer Phone | 8588365985 |
| Manufacturer G1 | RESMED LTD |
| Manufacturer Street | 1 ELIZABETH MACARTHUR DRIVE |
| Manufacturer City | BELLA VISTA, NSW 2153 |
| Manufacturer Country | AS |
| Manufacturer Postal Code | 2153 |
| 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 | 2012-10-31 |
| Model Number | 200002 |
| Catalog Number | 200002 |
| ID Number | PR522869 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED SAS - DENTAL SLEEP BUSINESS |
| Manufacturer Address | 292 ALLEE JACQUES MONOD PARC TECHNOLOGIQUE DE LYON SAINT PRIEST CEDEX 69791 FR 69791 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-31 |