MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-07 for FISHER WALLACE STIMULATOR 2 MA FW-100 manufactured by Fisher Wallace Laboratories.
[28311768]
Pt used a brain stimulator to stimulate neurochemical production. Experienced headaches and had a nightmares. Pt used a fisher wallace stimulator at least once between (b)(6) 2015 on a setting between 1 and 4 ma for anywhere from 1 to 20 minutes. Frequency: twice daily; route: transcranial. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056948 |
| MDR Report Key | 5148147 |
| Date Received | 2015-10-07 |
| Date of Report | 2015-10-07 |
| Date of Event | 2015-10-03 |
| Date Added to Maude | 2015-10-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FISHER WALLACE STIMULATOR 2 MA |
| Generic Name | CRANIAL STIMULATOR |
| Product Code | JXK |
| Date Received | 2015-10-07 |
| Model Number | FW-100 |
| Lot Number | PO-129 |
| Device Expiration Date | 2015-10-04 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER WALLACE LABORATORIES |
| Manufacturer Address | NEW YORK NY 10022 US 10022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-07 |