FISHER WALLACE STIMULATOR FW-100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-15 for FISHER WALLACE STIMULATOR FW-100 manufactured by Fisher Wallace Laboratories.

Event Text Entries

[55121309] I started use of a wallace fisher cranial electrical stimulation device saturday, (b)(6) 2016, that was purchased the week before use was at the recommended dose of 20 minutes on setting 2 twice a day. The first 2 nights, i had extremely vivid nightmares that i could not wake up from and was disoriented and unable to focus the remainder of the day. By the 3rd day of use (monday (b)(6)), i was unable to wake up until after 14 hours of sleep and was very disoriented, with difficulty in balance and coordination and a disoriented "drugged" feeling that lasted all day, greatly affecting my ability to concentrate, focus, make decisions and most other general cognitive processes, plus my memory was severely affected - for example my mother took me to a store where i could not remember why we went there or what i was supposed to get. By the 4th day, after 16 hours of sleeping, i required the aid of my mother in order to wake up, again having disorientation, incoordination and the drugged feeling making it impossible for me to completely perform anything that required focus, awareness or memory due to being in such a state of brain fog. In short, in 5 short days i went from being able to think clearly (i'm an animal behaviorist) to being a zone-out, stoner-like zombie. In addition to the above, my major depressive disorder has become much worse, with severe hopelessness, lack of interest in anything (i was found by both my spouse and mother staring blankly at a wall), with severely increased depression, anxiety, impatience and great hostility. My mother purchased this device for me to aid my depression because of the plethora of positive studies listed on the manufacturer's website and as i had been unable to be helped by pharmaceuticals due to so many adverse reactions, some life-threatening. Plus she bought this for me (as i have been unable to work due to my disability) at great hardship to herself as she only receives a small government pension. So to have paid so much for this device only to have my depression become worse is heart-crushing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5064789
MDR Report Key5955760
Date Received2016-09-15
Date of Report2016-09-15
Date of Event2016-09-12
Date Added to Maude2016-09-16
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameFISHER WALLACE STIMULATOR
Generic NameFISHER WALLACE STIMULATOR
Product CodeJXK
Date Received2016-09-15
Model NumberFW-100
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerFISHER WALLACE LABORATORIES


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-09-15

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