MECTA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for MECTA manufactured by Mecta Corporation.

Event Text Entries

[100888650] Not possible to followup on the injury report.
Patient Sequence No: 1, Text Type: N, H10

[100888651] Sever headaches, vision loss, nause/vomiting, painful muscles and joints, memory loss, anger, agitation, continual depression, dizziness, confusion, inability to focus after ect treatments in 2016.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3020533-2018-00010
• MDR Report Key: 7294048
• Date Received: 2018-02-23
• Date of Report: 2018-01-12
• Date of Event: 2016-06-06
• Date Mfgr Received: 2017-09-29
• Date Added to Maude: 2018-02-23
• 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: MRS. ROBIN NICOL
• Manufacturer Street: 19799 SW 95TH AVENUE SUITE B
• Manufacturer City: TUALATIN OR 97062
• Manufacturer Country: US
• Manufacturer Postal: 97062
• Manufacturer Phone: 5036126780
• Manufacturer G1: MECTA CORPORATION
• Manufacturer Street: 19799 SW 95TH AVENUE SUITE B
• Manufacturer City: TUALATIN OR 97062
• Manufacturer Country: US
• Manufacturer Postal Code: 97062
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: MECTA
• Generic Name: ECTDEVICE
• Product Code: GXC
• Date Received: 2018-02-23
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MECTA CORPORATION
• Manufacturer Address: 19799 SW 95TH AVE. SUITE B TUALATIN OR 97062 US 97062

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2018-02-23