BRAIN STATE TECHNOLOGIES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-11 for BRAIN STATE TECHNOLOGIES manufactured by Brain State Technologies.

Event Text Entries

[2525427] Brain state technologies of (b)(4) seriously need to be investigated. (b)(4) developed a technology he calls brain state conditioning which, in theory, uses quantum physics to balance people's brainwaves. After undergoing a series of sessions, i am now worse off than i ever was before and now see up online that others have also had very bad experiences with his technology. In essence, he and his technicians who buy a license to use the technology, are practicing a form of medicine without a license. I wish to remain anonymous and therefore, am not submitting the details of my particular case or else (b)(4) will know who i am. When things go wrong, i have learned he always places it back on the client that there is something wrong with the pt, not his technology. These people and their technology are extremely dangerous and crippling a segment of their clientele. While they claim that their technology is based on quantum physics and deny that it is neurofeedback, there is at least some sort of licensure/accreditation for practitioners to practice this alternative form of medicine. Brain state adheres to none of this. Please stop them from hurting others.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5024465
• MDR Report Key: 2475330
• Date Received: 2011-11-11
• Date of Report: 2011-11-11
• Date Added to Maude: 2012-03-07
• 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: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BRAIN STATE TECHNOLOGIES
• Generic Name: BRAIN STATE CONDITIONING
• Product Code: HCC
• Date Received: 2011-11-11
• Lot Number: NA
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BRAIN STATE TECHNOLOGIES
• Manufacturer Address: SCOTTSDALE AZ US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2011-11-11