MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-25 for THYMATRON SYSTEM IV EDIV manufactured by Somatics, Llc.
| Report Number | 1420295-2020-00003 |
| MDR Report Key | 9752278 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2016-08-23 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2005-10-14 |
| Date Added to Maude | 2020-02-25 |
| 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 MIRKOVICH |
| Manufacturer Street | 720 COMMERCE DRIVE SUITE 101 |
| Manufacturer City | VENICE, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 2346761 |
| Manufacturer G1 | SOMATICS, LLC |
| Manufacturer Street | 720 COMMERCE DRIVE SUITE 101 |
| Manufacturer City | VENICE, FL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THYMATRON |
| Generic Name | ELECTROCONVULSIVE THERAPY INSTRUMENT |
| Product Code | GXC |
| Date Received | 2020-02-25 |
| Model Number | SYSTEM IV |
| Catalog Number | EDIV |
| Lot Number | N/A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOMATICS, LLC |
| Manufacturer Address | 720 COMMERCE DRIVE SUITE 101 VENICE, FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2020-02-25 |