MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for AXONICS 1101 manufactured by Axonics Modulation Technologies, Inc..
| Report Number | 3002968685-2020-00026 |
| MDR Report Key | 9890895 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2019-11-23 |
| Date Added to Maude | 2020-03-27 |
| 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 | PETER VU |
| Manufacturer Street | 26 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA |
| Manufacturer Phone | 9493364590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXONICS |
| Generic Name | NEUROSTIMULATOR |
| Product Code | EZW |
| Date Received | 2020-03-27 |
| Model Number | 1101 |
| Catalog Number | 1101 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AXONICS MODULATION TECHNOLOGIES, INC. |
| Manufacturer Address | 26 TECHNOLOGY DRIVE IRVINE CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |