MAUDE Adverse Event Report: FISHER WALLACE LABS. FISHER WALLACE CRANIAL NEUROSTIMULATOR

Model Number FW-100

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Emotional Changes (1831); Headache (1880); Memory Loss/Impairment (1958); Irritability (2421); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Type  Injury  

Event Description

Experienced significant adverse effects after using the device such as headaches, irritability, emotionally unstable, temporal memory/concentration issue.

• Brand Name: FISHER WALLACE CRANIAL NEUROSTIMULATOR
• Type of Device: CRANIAL NEUROSTIMULATOR
• Manufacturer (Section D): FISHER WALLACE LABS.; 630 flushing ave; brooklyn 11206
• Manufacturer (Section G): NANJING WATT ELECTRIC MOTOR CO. LTD.,; no. 2 yihu road, lishui; economic development zone,; nanjing, jaingsu 21120 0; CH 211200
• Manufacturer Contact: gordon levites ; 630 flushing ave.; brooklyn 11206 ; 8006924380
• MDR Report Key: 16862298
• MDR Text Key: 314483061
• Report Number: 3006258094-2023-00006
• Device Sequence Number: 1
• Product Code: QJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: FW-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Date Device Manufactured: 05/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female