What Are Megadyne Pediatric Return Electrodes?

Megadyne pediatric return electrodes are typically used during electrosurgery. They come into contact with the patient’s skin and conduct electrical current from the tissue back to the surgical generator. This process is intended to minimize the risk of excessive heating.

Unfortunately, the product seems to cause burn injuries. The manufacturer recalled the product recently. 

The FDA Classifies Megadyne Pediatric Return Electrodes as Class I

In FDA terms, a **Class I recall** is the most serious type of recall. FDA uses it when there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.

The FDA classified Megadyne’s pediatric patient return electrode as a Class I recall. Patients reported suffering burn injuries after receiving the procedure. Soon after, Megadyne discontinued the product.

Not the First Recall

This isn’t the first time Megadyne’s electrodes have faced scrutiny. Last year, the company recalled various models of its Mega Soft and Mega 2000 electrodes. The Johnson & Johnson’s Ethicon division manufactures both models

The FDA also classified the Mega Soft electrodes as Class I because of similar concerns about burn injuries.

Not Just a Recall, a Market Withdrawal

The FDA is removing Mega Soft pediatric electrodes from the market (product 8040). Healthcare providers stop using this product on their patients.

The FDA cautioned that the use of the affected electrodes could result in severe health consequences for pediatric patients. Some of the dangers include third-degree burns, scarring, and the need for additional surgeries.

Who is Most at Risk? 

Users of the electrode pad are patients weighing less than 50 pounds, mostly infants and children.

The objective of the the product is to help children, However, this product puts children at greater risk.

Although Megadyne has reported no deaths, however, there have been a few injured patients.

What Can KBA Attorney’s Do?

If you or your child has suffered injuries by pediatric return electrodes, there are several steps that you can take. Our law firm can assist those who have suffered by providing expert legal counsel and representation. Contact Us and we can help parents of victims navigate the complex legal process for their children.