MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-08-25 for BRAIN STATE CONDITION manufactured by Brain State Condition.
[18242109]
Reporter states that she is unable to sleep and feels like she is in a coma after using the brain state condition device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008067 |
| MDR Report Key | 1132904 |
| Date Received | 2008-08-25 |
| Date of Report | 2008-08-25 |
| Date of Event | 2008-06-01 |
| Date Added to Maude | 2008-09-02 |
| 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 |
| Brand Name | BRAIN STATE CONDITION |
| Generic Name | BRAIN STATE CONDITION |
| Product Code | HCC |
| Date Received | 2008-08-25 |
| Operator | LAY USER/PATIENT |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1144377 |
| Manufacturer | BRAIN STATE CONDITION |
| Manufacturer Address | 15150 N HAYDEN RD SUITE 106 SCOTTSDALE AZ 85260 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-25 |