MAUDE Adverse Event Report: FISHER-WALLACE LABORATORIES, INC. FISHER WALLACE STIMULATOR; CRANIAL ELECTROTHERAPY STIMULATOR TO TREAT DEPRESSION

Model Number FW-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Headache (1880); Weakness (2145); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

Used as directed at power setting #2 for 20 minutes, once per day, on 3 different days.Each time i was left with a persistent headache, very shaky hands, a feeling of weakness and fatigue.Fda safety report id# (b)(4).

• Brand Name: FISHER WALLACE STIMULATOR
• Type of Device: CRANIAL ELECTROTHERAPY STIMULATOR TO TREAT DEPRESSION
• Manufacturer (Section D): FISHER-WALLACE LABORATORIES, INC.
• MDR Report Key: 10413262
• MDR Text Key: 203303665
• Report Number: MW5096089
• Device Sequence Number: 1
• Product Code: JXK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FW-100
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 73