MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-24 for SOMATICS, LLC manufactured by Somatics, Llc.
[142931785]
The company has received a legal complaint and is unable to investigate due to legal constraints within the allotted reporting period. As a result, the company is reporting out of abundance of caution based solely on the allegations contained in the lawsuit. If and when the company is permitted to conduct a proper investigation, it will be able to determine if its device caused the alleged injuries. The information currently available suggests that it is unlikely. The december 2018 fda publication stated there is no proof that ect causes this injury. Somatics will supplement this report accordingly.
Patient Sequence No: 1, Text Type: N, H10
[142931786]
Ms. (b)(6) filed a lawsuit claiming multiple "serious" injuries. Some of these alleged injuries are: brain damage; neurocognitive injuries; permanent memory loss; and several other alleged injuries since this is just the beginning of the lawsuit somatics will not be able to confirm any of these allegations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420295-2019-00005 |
| MDR Report Key | 8545182 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date Mfgr Received | 2019-04-06 |
| Date Added to Maude | 2019-04-24 |
| 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 | DAVID MIRKOVICH |
| Manufacturer Street | SUITE 101 720 COMMERCE DRIVE |
| Manufacturer City | VENICE FL 34292 |
| Manufacturer Country | US |
| Manufacturer Postal | 34292 |
| Manufacturer Phone | 8006426761 |
| Manufacturer G1 | SOMATICS, LLC |
| Manufacturer Street | SUITE 101 720 COMMERCE DRIVE |
| Manufacturer City | VENICE FL 34292 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34292 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOMATICS, LLC |
| Generic Name | THYMATRON SYSTEM IV |
| Product Code | GXC |
| Date Received | 2019-04-24 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOMATICS, LLC |
| Manufacturer Address | SUITE 101 720 COMMERCE DRIVE VENICE FL 34292 US 34292 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-24 |