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 08/16/2022

Event Type  malfunction  

Event Description

Twice a day, 20 minutes, most of the time when i turned it on, i had to open the battery case and realign the batteries because they somehow shifted out of place even with a lid secured.I didn't mention it because it worked fine once i clicked the batteries back in place.But yesterday it stopped working in the middle of a session and when i opened the battery case, one of the batteries had peeled and was hot to the touch.Very hot.Too hot to touch.After getting the batteries out, the piece with the spring on it came out with the batteries.There was a slot for it, so it was very easy to put back in.The problem of the batteries being out of place has resolved itself since i put the new batteries in.I don't know if this is significant or not, but i thought i would mention it.I have been using level four for about a week now.I have one more week to go in my trial.I have mild ptsd, chronic but erratic migraines, relatively mild insomnia, and anxiety dreams every night.I no longer have terrifying nightmares.I'm using the dreams as a test because everything else is too inconsistent.I have had a couple of dreams in which i recognize that i did not have to stay in the anxiety producing situation.But i can't actually say that that is a significant improvement.

• 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: 16862923
• MDR Text Key: 314809113
• Report Number: 3006258094-2023-00034
• 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: 11/04/2022

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?: No
• 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 Age: 72 YR
• Patient Sex: Female