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

Model Number FW-100

Device Problems Defective Component (2292); Defective Device (2588)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  malfunction  

Event Description

I have the fisher wallace device and have used it for about a month in a half solidly.I have had very excellent results and am sleeping and feeling better for the first time in a long time.I have been very happy, however, tonight it broke.It became very hot and when i took off the battery cover, one of them was melting.I quickly shook them out of the device.One battery was spitting and melted.The device no longer works.I havent had it very long so i am guessing it is under warranty.

• 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: 16862006
• MDR Text Key: 314498447
• Report Number: 3006258094-2023-00037
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 12/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 91982
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female