MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-09-09 for NOMAD DENTAL 60KV 0.850.0000 FP 0001 manufactured by Airbex.
| Report Number | 1017522-2019-00014 |
| MDR Report Key | 8975474 |
| Report Source | USER FACILITY |
| Date Received | 2019-09-09 |
| Date of Report | 2019-09-09 |
| Date of Event | 2019-08-12 |
| Date Mfgr Received | 2019-08-12 |
| Device Manufacturer Date | 2007-03-15 |
| Date Added to Maude | 2019-09-09 |
| 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 | 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 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877297 |
| Manufacturer G1 | AIRBEX |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOMAD DENTAL 60KV |
| Generic Name | EXTRAORAL SOURCE X-RAY SYSTEM |
| Product Code | EHD |
| Date Received | 2019-09-09 |
| Returned To Mfg | 2019-08-20 |
| Model Number | 0.850.0000 |
| Catalog Number | FP 0001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIRBEX |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-09 |