NEUROFEEDBACK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-24 for NEUROFEEDBACK manufactured by Eeg Info.

Event Text Entries

[39570113] My name is (b)(6) i have bought this device neurofeedback from (b)(6). This company "claims lies", filters negative reviews, threatens those who speak out. They sold the device without a prescription. Misbranding leading to serious disabling adverse effects, severe memory and cognitive impairment. Eeg testing "amiable" harming ability to function leading to ticks and academic dismissal. Worse, they refuse to fix it! I am willing to sit and monitor my conditions. They try to raise public against fda and (b)(6) that this device is safe. This device is dangerous, i had it. I had 300 sessions, even more drugs i take now to ward off its adverse effect. "is not helping". This company, is a scam they do, from waste abuse as well as scamming veterans. What can you do, it ruins my life. They send threats every time i post to (b)(6) and they use their employees to put fake reviews on their site and some other site. They are criminals and you can use my result to recall this device and seize them. I am proof of injury.
Patient Sequence No: 0, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5060572
• MDR Report Key: 5466482
• Date Received: 2016-02-24
• Date of Report: 2016-02-24
• Date of Event: 2016-02-24
• Date Added to Maude: 2016-02-29
• 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
• Reporter Occupation: PATIENT
• 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: NEUROFEEDBACK
• Generic Name: NEUROFEEDBACK
• Product Code: HCC
• Date Received: 2016-02-24
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: EEG INFO

Patients

Patient Number	Treatment	Outcome	Date
0	0	1. Other; 2. Required No Informationntervention; 3. Deathisabilit	2016-02-24