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 N/A manufactured by Somatics, Llc.
[180806469]
Somatics became aware of this event through the anonymously submitted mw5092553 report, which does not provide any contact information for the complainant, the treating physician or facility, nor any additional information about the complainant, or circumstances surrounding the reported event. The mw report also does not provide any laboratory results, or other objective information to corroborate the complainant's reporting of the adverse effects suffered in relation to electroconvulsive therapy. The report does not identify which device model was used in the treatments. Because of the lack of identifying information, somatics is unable to follow up with any involved parties to learn what happened or to confirm whether the complainant was even treated with a somatics device. Moreover, the medical literature provides no evidence of the connection drawn by the complainant between ect treatments and the symptoms reported. Although somatics has determined that the subject event in the mw report is not likely reportable, because somatics is unable to follow up with the complainant and / or confirm the ect device in question was manufactured by somatics, we are submitting this report to the fda in abundance of caution and to ensure full compliance with 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
[180806470]
Complainant checked several of the boxes to describe the injuries reportedly suffered six (6) years ago. The where no supporting information attached to the mw5092553 report
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420295-2020-00002 |
| MDR Report Key | 9751182 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-25 |
| Date of Report | 2020-01-24 |
| Date of Event | 2014-07-08 |
| Date Mfgr Received | 2020-02-10 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 |
| Removal Correction Number | MW5092553 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THYMATRON |
| Generic Name | ECT MEDICAL INSTRUMENT |
| Product Code | GXC |
| Date Received | 2020-02-25 |
| Model Number | N/A |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Deathisabilit | 2020-02-25 |