MAUDE MDR 746922

MDR report key
746922
Report number
MW1036795
Event key
0
Event type
3
Date of event
2005-01-20
Date received
2005-10-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIOCOMP RESEARCH INSTITUTENEAR INFRARED SPECTROSCOPIC BIOFEEDBACK DEVICE ALSO CALLEDBIOCOMP RESEARCH INSTITUTEHCCNOT SURE**NY
2POCKET-NEUROBICSNEAR INFRARED SPECTROSCOPIC BIOFEEDBACK DEVICE ALSO CALLED 'POCKET-NUROBICSHCCNOT SURE**NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-10-0201. O

Event Narratives#

D

Patient 1

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.