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 |