MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-08-09 for STMS MINI DWG-0500 manufactured by Eneura, Inc..
| Report Number | 3008487930-2019-00001 |
| MDR Report Key | 8879917 |
| Report Source | CONSUMER |
| Date Received | 2019-08-09 |
| Date of Report | 2019-07-17 |
| Date of Event | 2019-07-17 |
| Date Mfgr Received | 2019-07-17 |
| Date Added to Maude | 2019-08-09 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CYNTHIA MERRELL |
| Manufacturer Street | 715 N. PASTORIA AVE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer G1 | ENEURA, INC. |
| Manufacturer Street | 715 N. PASTORIA AVE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STMS MINI |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATOR |
| Product Code | OKP |
| Date Received | 2019-08-09 |
| Model Number | DWG-0500 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENEURA, INC. |
| Manufacturer Address | 715 N. PASTORIA AVE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-09 |