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 Headache (1880); Tinnitus (2103)

Event Type  Injury  

Event Description

I have had my unit for about 3 weeks and have been using it regularly with mixed success.I really want to love it.I am concerned about the tinnitus i experience for up to 24 hours past usage as well as headaches (i go them bigtime in the beginning , not so much now).Can you please speak to these? i am concerned the unit and i may not be a good fit.Moreso, damage! should that be the case, please advise the procedure to return it.

• Brand Name: FISHER WALLACE CRANIAL NEUROSTIMULATOR
• Type of Device: CRANIAL NEUROSTIMULATOR
• Manufacturer (Section D): FISHER WALLACE LABS; 630 flushing ave; brooklyn NY 11206
• Manufacturer (Section G): NANJING WATT ELECTRIC MOTOR CO. LTD.,; no. 2 yihu road, lishui; economic development zone,; nanjing, jiangsu 21120 0; CH 211200
• Manufacturer Contact: gordon levites ; 630 flushing ave; brooklyn, NY 11206 ; 8006924380
• MDR Report Key: 16862005
• MDR Text Key: 314480079
• Report Number: 3006258094-2023-00023
• 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

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: 11/23/2022
• 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