URGENT: MEDICAL DEVICE CORRECTION (FW-100)
Fisher Wallace Laboratories, Inc.
April 6, 2023
URGENT: MEDICAL DEVICE CORRECTION
Fisher Wallace Stimulator Model #: FW-100
Dear Device User,
Fisher Wallace Laboratories, Inc. (“Fisher Wallace”) is voluntarily correcting the labeling for the Fisher Wallace Stimulator, Model #: FW-100, due to concerns that AA batteries may overheat if they are incorrectly installed. If AA batteries are incorrectly installed into the device (installed backwards), the batteries and battery cover may become hot, possibly leading to pain, discomfort, irritation, or burns if they are touched. We have no evidence that there is a fire risk.
Fisher Wallace is aware of thirteen (13) complaints related to excess heat of the Fisher Wallace Stimulator battery cover, recorded as thirteen (13) medical device reports (MDRs) that relate to this issue. Of these thirteen (13) complaints, two (2) customers complained of burning their fingers when touching the batteries and/or battery cover, but did not require medical intervention.
Our records indicate you have received the Fisher Wallace Stimulator model FW-100. The device model/type may be identified by reviewing the device’s back label field titled “Model” where the specific model (e.g., FW-100) of the product is described. Affected serial numbers include 2020200000-2022278000. The serial number can be found on the device’s back label field titled “Serial Number.”
See below example picture:
Risk to Health:
To avoid potential excess heat of the Fisher Wallace Stimulator FW-100, users are instructed to ensure that the AA batteries that power the device are inserted with the correct orientation, consistent with the diagram found in the battery compartment. Failure to insert the batteries correctly may cause the batteries and battery cover to overheat, possibly leading to pain, discomfort, irritation, or burns if they are touched. We have no evidence that there is a fire risk.
Please retain a copy of this communication with your instructions for use to ensure proper placement of batteries into the device as referred to in the diagram below.
How to recognize that the device is failing:
If the Fisher Wallace Stimulator FW-100 exhibits excess heat, the user is instructed to turn off the device, wait until the device cools, and check the battery compartment for any sign of damage, such as but not limited to a burning smell or discoloration. If this occurs, please contact Fisher Wallace Laboratories at the phone number or email provided below.
The user may also identify this issue if there is:
• Failure of the device LED lights to illuminate, even when the sponges are sufficiently wet;
• Failure of the device’s electrode assembly to output the level of stimulation selected by the user, even when the sponges are sufficiently wet;
• Failure of the device to power up to its initial standby mode (i.e., lack of green light).
Short term actions to be taken by the User:
The long term corrective action by the company is still being determined.
Product and Distribution Information:
The table below outlines the serial number range for all 43,742 FW-100 devices that could produce this issue.
|Product Model Number/ Serial Number Range
|Fisher Wallace Stimulator
|Serial Numbers: 2020200000-2022278000
This voluntary action is being made with knowledge of the Food and Drug Administration.
Adverse reactions or quality problems experienced with the use of this device may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
We request your action by replying to this email to confirm that you understand the information in this medical device correction and the subsequent actions needed to be taken.
Fisher Wallace apologizes for any inconvenience this may cause. If you have any questions about what to do with your product, please contact Fisher Wallace by telephone Monday - Friday, 10:00 AM to 6:00 PM, Eastern Time at (800) 692-4380 or by email at email@example.com.
CEO, Fisher Wallace Laboratories, Inc.