FDA Adverse Event
Malfunction
Summary report: N
FISHER WALLACE CRANIAL NEUROSTIMULATOR
MDR report key: 16862006
·
Received May 3, 2023
Report
- Report Number
- 3006258094-2023-00037
- Event Type
- Malfunction
- Date Received
- May 3, 2023
- Report Date
- October 24, 2022
- Manufacturer
- FISHER WALLACE LABS
- Product Code
- QJQ
- PMA / PMN Number
- K903654
- Removal / Correction Number
- RES 91982
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
I HAVE THE FISHER WALLACE DEVICE AND HAVE USED IT FOR ABOUT A MONTH IN A HALF SOLIDLY. I HAVE HAD VERY EXCELLENT RESULTS AND AM SLEEPING AND FEELING BETTER FOR THE FIRST TIME IN A LONG TIME. I HAVE BEEN VERY HAPPY, HOWEVER, TONIGHT IT BROKE. IT BECAME VERY HOT AND WHEN I TOOK OFF THE BATTERY COVER, ONE OF THEM WAS MELTING. I QUICKLY SHOOK THEM OUT OF THE DEVICE. ONE BATTERY WAS SPITTING AND MELTED. THE DEVICE NO LONGER WORKS. I HAVENT HAD IT VERY LONG SO I AM GUESSING IT IS UNDER WARRANTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 533820 | FISHER WALLACE CRANIAL NEUROSTIMULATOR | CRANIAL NEUROSTIMULATOR | QJQ | FISHER WALLACE LABS | FW-100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |