MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-29 for BIOCOMP OR POCKET NEUROBICS HEG * manufactured by Biocomp Research Inst.
[532079]
A co named biocomp research corp, is selling fake near-infrared spectroscopic devices to hundreds of disabled people. Many more units have been sold to unsuspecting clinicians and are being used to provide sham neurofeedback therapy to their pts. I suspect the number of therapists is more than 100 and perhaps a hundred thousand hours of time has been spent administrating worthless and false "therapy" with this device. Owner uses empirical studies compiled by hamamatsu - currently seeking fda approval and mfr of clinical grade near - infrared spectroscopy - to deceive propsective customers into believing the biocomp device is authentic. He sells his device illegally to anybody via telephone and does not have a license to practice medicine. A complete list of his false and outrageous claims to alleviate the symptoms of epilepsy, multiple sclerosis, aging, add, autoimmune disorders, dementia, alzheimer's, and virtually every known malady to afflict mankind can be found on the biocomp website. Please stop the fraudulent distribution, misrepresentation, false claims and criminal conduct of this individual.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036470 |
| MDR Report Key | 751541 |
| Date Received | 2005-08-31 |
| Date of Report | 2005-08-29 |
| Date of Event | 2004-02-01 |
| Date Added to Maude | 2006-08-18 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOCOMP OR POCKET NEUROBICS HEG |
| Generic Name | BIOFEEDBACK NEAR-INFRARED SPECTROSCOPIC DEVICE - NIR - |
| Product Code | HCC |
| Date Received | 2005-08-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 739354 |
| Manufacturer | BIOCOMP RESEARCH INST |
| Manufacturer Address | * LOS ANGELES CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-31 |