CYGNET EEG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-01 for CYGNET EEG manufactured by Bee Systems.

Event Text Entries

[44575966] I had 300 total sessions of neurofeedback, more than anyone for major depression, adhd 100. Of them "were other plan" by eeg info cygnet just to get little buzz, as any energy drink promised. This junk cures. Spent total (b)(6) for treatment. Practitioner was listed as md, but he was a scammer. They suggested to me and all his patients to buy the device without prescription or safety hazard. Lead to serious adverse effect, harm to coherence, ticks, car accident, dysfunction, severe agitation, deletion, impairment of short term memory, and serious learning problem. I was not able to follow instruction and company couldn't fix it. It's long term and disables me. I can't drive same areas, it ruined my life. I hope owner goes to jail. I'm open to media. Brain testing speaks for itself. I'm open to medwatch. Experts, you can easily hurt yourself long term not established". Scam is go more you be cured". Recently due to worsening and add'l adverse effect.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5062066
• MDR Report Key: 5630032
• Date Received: 2016-05-01
• Date Added to Maude: 2016-05-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CYGNET EEG
• Generic Name: CYGNET EEG
• Product Code: HCC
• Date Received: 2016-05-01
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BEE SYSTEMS

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-05-01