BIOCOMP RESEARCH INSTITUTE NOT SURE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-02 for BIOCOMP RESEARCH INSTITUTE NOT SURE * manufactured by Biocomp Research Institute.

Event Text Entries

[516376] The equipment in question is made by both pocket-neurobics and biocomp research institute. It is called a near-infrared spectroscopic biofeedback device. The claims made are identical and totally false. Neither has any medical license or medical degree. Both are electrical engineers. The first lives and produces his pocket-neurobics junk in a foreign country. He ships the fake devices to the usa where they are distributed and sold illegally by other individuals, one of whom is the second. They have sold hundreds to suffering victims and parents of disabled children. There is no money back quarantee. Another non-licensed distributor located in florida. He has already been prosecuted for fda violations. This equipment claims to penatrate the human skull and detect cerebral metabolism thereby allowing the individual to grow new brain cells and blood vessels. Obviously this cannot be true, but even worse, the device does not penetrate the skull at all. The unfortunate victim of this con artistry will try and try to increase the readings and eventually get a massive migraine headache. I was about to have another stroke when i stopped further efforts. Both cons have references on their websites to studies of actual clinical-grade equipment manufactured by hamatsu, nim, and hitachi, all of whom are either seeking or are working to achieve fda approval. Neither hamatsu, nim, or hitachi will sell their equipment without carefully mandated fda oversight and regulations requiring a dr's approval. The first mfr even has an outrageous list of medical problems he claims will be cured or alleviated on his site including alzheimer's, dementia, aging, depression, epilepsy, multiple sclerosis, etc. Both will sell this crap over the internet or telephone to anybody with a checking account or credit card and do not even ask for a dr's referral. They also do not provide any advice or counseling whatsoever for application to specific conditions. Please stop these criminals and their false claims from continuing to commit fraud and misrepresent their harmful junk.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW1036795
MDR Report Key746922
Date Received2005-10-02
Date of Report2005-10-02
Date of Event2005-01-20
Date Added to Maude2006-08-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameBIOCOMP RESEARCH INSTITUTE
Generic NameNEAR INFRARED SPECTROSCOPIC BIOFEEDBACK DEVICE ALSO CALLED
Product CodeHCC
Date Received2005-10-02
Model NumberNOT SURE
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key734712
ManufacturerBIOCOMP RESEARCH INSTITUTE
Manufacturer Address6642 HAYES DR LOS ANGELES CA * US

Device Sequence Number: 2

Brand NamePOCKET-NEUROBICS
Generic NameNEAR INFRARED SPECTROSCOPIC BIOFEEDBACK DEVICE ALSO CALLED '
Product CodeHCC
Date Received2005-10-02
Model NumberNOT SURE
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key734719
ManufacturerPOCKET-NUROBICS
Manufacturer Address6642 HAYES DR LOS ANGLES CA * US

Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-10-02
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.