MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-22 for NUERA GA-5000020 manufactured by Bios Srl.
| Report Number | 1720381-2019-00011 |
| MDR Report Key | 9218007 |
| Date Received | 2019-10-22 |
| Date of Report | 2019-10-22 |
| Date of Event | 2019-09-28 |
| Date Facility Aware | 2019-09-28 |
| Report Date | 2019-10-02 |
| Date Reported to Mfgr | 2019-10-02 |
| Date Added to Maude | 2019-10-22 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUERA |
| Generic Name | FAMILY OF RADIOFREQUENCY SYSTEM (BIOREVITAL RF MED, THERMISMOOTH 250) |
| Product Code | PBX |
| Date Received | 2019-10-22 |
| Model Number | NUERA |
| Catalog Number | GA-5000020 |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOS SRL |
| Manufacturer Address | VIA GUIDO ROSSA, 10/12 VIMODRONE, 20090 IT 20090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-22 |