MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-28 for NEUROFEEDBACK CYGNET EEG C510137 manufactured by .
[19721578]
Very complicated device sold without prescription; practitioner was not md. I became worse and got in a car accident. Adverse effects: sever ticks, impulsivity, rage, personality change, confusion, memory problems, inability to observe info, poor and very sluggish time reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042454 |
| MDR Report Key | 4745550 |
| Date Received | 2015-04-28 |
| Date Added to Maude | 2015-05-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| 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 |
| Brand Name | NEUROFEEDBACK CYGNET EEG |
| Generic Name | EEG |
| Product Code | HCC |
| Date Received | 2015-04-28 |
| Catalog Number | C510137 |
| ID Number | CE1275 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2015-04-28 |