MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-22 for MECTA CORPORATION manufactured by .
[139610729]
The report mw 5067590 was dated (b)(6) 2018 but referenced the event date as (b)(6) 2010. The report listed references to articles written over the years that had the mecta spectrum 5000q as the primary medical device. This is not manufactured by somatics. There was a mention of an article written in 1999 that referred to a thymatron dgx which was made by somatics. This report does not provide any contact information for the patients mentioned in the articles, no information for the treating physician, facility, laboratory results or any objective information. The primary focus of the report was the mecta medical device, which is not manufactured by somatics. At the time of this report in january 2018, the company determined that the reported events in the mw 5067590 were not related to somatics and there was no way to follow-up with any complainant. The company is now submitting this report to the fda in an abundance of caution and to ensure full compliance with 21 cfr part 803. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139610730]
This report, mw 5067590 was sent to reference articles written many years earlier that described mecta spectrum units, not manufactured by somatics. It also mentioned an article from 1999 about a thymatron dgx device made by somatics. The event date was listed as (b)(6) 2010 but the report was dated (b)(6) 2017. There was no information about any complainants, physicians, hospital, laboratories, just references to previous articles.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420295-2019-00004 |
| MDR Report Key | 8445246 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date of Event | 2010-01-01 |
| Date Mfgr Received | 2018-01-02 |
| Date Added to Maude | 2019-03-22 |
| 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 | 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 | MECTA CORPORATION |
| Generic Name | MECTA SPECTRUM 5000 Q AND FROM 1999 THYMATRON DGX |
| Product Code | GXC |
| Date Received | 2019-03-22 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-22 |