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

My stimulator is making a burning smell and only the bottom light turns o\n.I need advice or a repair badly.Have replaced batteries.Seems dangerous now.

• 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, jiangsu 21120 0; CH 211200
• Manufacturer Contact: gordon levites ; 630 flushing ave; brooklyn, NY 11206 ; 8006924380
• MDR Report Key: 16862023
• MDR Text Key: 314548640
• Report Number: 3006258094-2023-00040
• 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: 12/30/2022

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?: 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