FDA issues warning of burn risk with Megadyne grounding pads in animals

Officials at the FDA Center for Veterinary Medicine (CVM) are warning those in the veterinary space about a recall for Megadyne grounding pads in humans. On Jan. 14, they released a Dear Veterinarian letter advising the veterinary community of possible issues. The CVM has received reports of burn injuries associated with these human medical devices in both children and animals. Because some veterinary practices also utilize these products, caution is advised.

The recall includes Megadyne MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Patient Return Electrodes. This indicates that use of the product could result in “serious injury or death” if the FDA’s updated instructions for use (which mainly apply to use in humans) are not followed.  

The risk

Megadyne grounding pads are meant to direct electric current and heat away from the patient. However, burn injuries, including third-degree burns, scarring, and the need for additional surgeries have been reported with their use. These complications have occurred in both children under 12-years-old and dogs of different ages and weights.   

Furthermore, the recall does not remove the devices from the market or instruct veterinarians not to use them. However, it does dictate that they are not to be used with children under the age of twelve or with human patients weighing less than 25 pounds.  

Veterinarians and animal owners are encouraged to report any adverse experiences associated with Megadyne grounding pads to the FDA. Finally, instructions to report an adverse experience can be found here.  

Photo credit: US Federal Drug Administration Center for Veterinary Medicine

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