MAUDE Adverse Event Report: SOMATICS, LLC MECTA CORPORATION; MECTA SPECTRUM 5000 Q AND FROM 1999 THYMATRON DGX

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

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.

• Brand Name: MECTA CORPORATION
• Type of Device: MECTA SPECTRUM 5000 Q AND FROM 1999 THYMATRON DGX
• Manufacturer (Section G): SOMATICS, LLC; suite 101; 720 commerce drive; venice FL 34292
• Manufacturer Contact: david mirkovich ; suite 101; 720 commerce drive; venice, FL 34292 ; 8006426761
• MDR Report Key: 8445246
• MDR Text Key: 139610729
• Report Number: 1420295-2019-00004
• Device Sequence Number: 1
• Product Code: GXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 890711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other