MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-08 for BEST SYSTEM MERIDIAN STRESS ASSESSMENT manufactured by Biomeridian, Inc..
[136559]
A counselor and supervisor from the vocational rehabilitation called asking for info about fda device classification and approval. They have a client with mental illness who is asking the state agency to pay for the best system meridan stress assessment computerized device and training. They faxed a copy of the 510(k) letter for this device and the product brochure. The product brochure claims that by using the system "a trained practitioner or technician can then interpret the stress conditions of a particular organ system. " the distributor verbally claimed this device can diagnose various medical conditions including cancer. When the agency e-mailed the distributor asking about the depth of training required, all they learned was the cost was $20,000. Device was not purchased. Unknown if device is imported. Problem keyword: fraud.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002621 |
| MDR Report Key | 245173 |
| Date Received | 1999-10-08 |
| Date of Report | 1999-10-05 |
| Date Added to Maude | 1999-10-20 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEST SYSTEM MERIDIAN STRESS ASSESSMENT |
| Generic Name | GALVANIC SKIN RESPONSE DEVICE |
| Product Code | GZO |
| Date Received | 1999-10-08 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | K943101 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 237532 |
| Manufacturer | BIOMERIDIAN, INC. |
| Manufacturer Address | 13526 SOUTH 110 WEST DRAPER UT 840208671 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-10-08 |