MAUDE MDR 2475330

MDR report key
2475330
Report number
MW5024465
Event key
0
Event type
3
Date received
2011-11-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BRAIN STATE TECHNOLOGIESBRAIN STATE CONDITIONINGBRAIN STATE TECHNOLOGIESHCCNA N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-11-1101. R

Event Narratives#

D

Patient 1

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.