MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-19 for JOURNEY TO THE WILD DIVINE * manufactured by *.
[458455]
I recently purchased a device called journey to the wild divine. It is labelled as a biofeedback device. Www. Wilddivine. Com. From my understanding as a clinician, this device requires fda 510k approval and prescription labelling, since it is not battery powered. Indeed, it derives its power from the usb cable from the pc. Our biomedical technician at the hosp measured the resistance from the fingertip skin conductance sensors to the usb cable and found it to be only 28,8000 ohms. In the case of a short circuit in a pc running 220 vac or 110 vac, the current to a user could exceed 7. 8 milliamperes - far higher than the maximum allowed of approximately 100 microamperes - and potetially hazardous. I spoke with the co, and they are aware of the situation, but claim they are legal. As a clinician dealing with susceptible pts, i am very concerned- especailly since this product is being sold mostly to consumers. In additon, they are making claims for the product outside of the rhealm of relaxation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038742 |
| MDR Report Key | 709373 |
| Date Received | 2006-04-19 |
| Date of Report | 2006-04-19 |
| Date of Event | 2006-04-19 |
| Date Added to Maude | 2006-05-10 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JOURNEY TO THE WILD DIVINE |
| Generic Name | JOURNEY TO THE WILD DIVINE |
| Product Code | HCC |
| Date Received | 2006-04-19 |
| Model Number | JOURNEY TO THE WILD |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 698418 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-19 |