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

Hello, i sent out an email last week regarding the pads replacement.Thank you for the new ones.I'm having issues with the control.I replaced the batteries and it heated up, and it smelled like burning plastic so i removed the battery again.Can the control be replaced too?.

• 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: 16862010
• MDR Text Key: 314500554
• Report Number: 3006258094-2023-00041
• 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
• Type of Report: Initial
• Report Date: 02/02/2023

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?: No
• 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