MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-22 for SOMATICS, LLC N/A manufactured by Somatics, Llc.
[175852416]
The person reporting the adverse event, mw5091900, stated he/she received 179 treatments in 2002 - 2003 and 8 more in 2005. These dates are 15 to 18 years ago. There was no mention of the hospital(s) or doctor(s) or device(s), just general allegations of memory loss. The text provided indicated the person had already been on disability in 1998 and had taken medications that could cause the problems reported. Trying to error on the side of caution, somatics sent a registered letter requesting specific information so we could asses the allegations. In the past individuals have made generic claims of problems without providing any means to determine if our medical device was involved. Without any health professional or hospital information, somatics cannot asses any accuracy to these allegations.
Patient Sequence No: 1, Text Type: N, H10
[175852417]
Person filing the adverse event claimed there were 179 treatments in 2002 - 2003 and 8 in 2005. These treatments allegedly resulted in memory loss. There was no proof provided in the mw document as to which hospital(s) or doctor(s) were involved or which device(s) were used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420295-2020-00001 |
| MDR Report Key | 9615844 |
| Report Source | OTHER |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-22 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-01-22 |
| 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 34292 |
| Manufacturer Country | US |
| Manufacturer Postal | 34292 |
| Manufacturer Phone | 8472346761 |
| Manufacturer G1 | SOMATICS, LLC |
| Manufacturer Street | 720 COMMERCE DRIVE SUITE 101 |
| 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 |
| Product Code | GXC |
| Date Received | 2020-01-22 |
| Model Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 34292 US 34292 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-22 |