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 Problem Electric Shock (2554)

Event Type  Injury  

Event Description

People that have metal in their heads should not use this product.I spent (b)(6) on it and was hoping for some good results and realized i was seeing the metal coils in my head.Felt like electrocuting behind my eyes.

• 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: 16863074
• MDR Text Key: 314491417
• Report Number: 3006258094-2023-00044
• 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: 01/08/2023

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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female