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 Date 10/16/2022

Event Type  malfunction  

Event Description

Used twice a day, morning and night.Holding device in the hand, heard a crack', burned thumb - device went to lvl.4 on its own, you saw lightning across your vision, threw off the device.And equipment.Headache persisted.

• 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: 16862002
• MDR Text Key: 314889836
• Report Number: 3006258094-2023-00036
• 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: 10/21/2022

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: 10/24/2022
• 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 Age: 33 YR
• Patient Sex: Female