MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-20 for NOMAD PRO2 0.850.0025 FP 0190 manufactured by Aribex.
| Report Number | 1017522-2020-00002 |
| MDR Report Key | 9733047 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-01 |
| Device Manufacturer Date | 2017-03-20 |
| Date Added to Maude | 2020-02-20 |
| 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 WATERS |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE, NC |
| Manufacturer Country | US |
| Manufacturer Phone | 5877297 |
| Manufacturer G1 | ARIBEX |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE, NC |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOMAD PRO2 |
| Generic Name | EXTRAORAL SOURCE X-RAY SYSTEM |
| Product Code | EHD |
| Date Received | 2020-02-20 |
| Model Number | 0.850.0025 |
| Catalog Number | FP 0190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARIBEX |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE, NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |