MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-06 for NEUROFEEDBACK manufactured by .
[22042143]
Pt states she had neurofeedback procedure done twice by dr. (b)(6) and ever since then her delusional disorder has come back and has gotten worse. Pt also complained about extreme anxiety attacks, fear, loss of appetite, not trusting people. Pt states she has been unable to work ever since neuro feedback procedure and feels this procedure is extremely dangerous to people with mental illness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024144 |
| MDR Report Key | 2442427 |
| Date Received | 2012-02-06 |
| Date of Report | 2012-02-06 |
| Date of Event | 2012-01-04 |
| Date Added to Maude | 2012-02-09 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NEUROFEEDBACK |
| Product Code | HCC |
| Date Received | 2012-02-06 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-06 |