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Megadyne Electrode Lawsuit (2024 Recall Info)

Megadyne is recalling more than 21,000 Megadyne Patient Return Electrodes after the company received at least 63 reports of serious burn injuries in both pediatric and adult patients.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt
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Update: Additional Megadyne Electrodes Recalled Over Burn Injury Risk to Children

According to the FDA’s latest notice, Megadyne has issued a new recall for its MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes after the company received at least 4 reports of burn injuries to children under the age of 12 associated with the devices, according to an FDA Recall Letter published on May 10, 2024 [1].

This recall affects the following products:

Product Name

Product Code

UDI-DI

MEGADYNE™ MEGA SOFT™
Pediatric Patient Return Electrode
0840 10614559103395

According to the FDA, the problem with the recalled Megadyne Electrodes resulted from a combination of factors that increase the risk of thermal burn injuries.

The combination of these conditions may be more likely when the pad is used with infants and small children, FDA said. Because the pediatric pad is designed for patients between 0.8 to 50 pounds, which would be predominantly patients under the age of 12, the decision was made to discontinue and recall the 0840 pediatric pad product.

If you purchased a MEGADYNE MEGA SOFT Pediatric Patient Return Electrode that is affected by this recall, you should stop using it immediately and return it to the point of purchase for a full refund. According to the FDA, Megadyne is notifying global customers and distributors by mail and arranging for the return of the impacted product.

Serious Burn Injuries Linked to Megadyne Patient Return Electrodes: FDA Warning

According to a Recall Notice, burns caused by Megadyne Patient Return Electrodes may be as serious as 3rd-degree burns requiring medical intervention which may require a longer hospital stay, scarring, and potentially more surgeries for pediatric and adult patients [2] issued by the U.S. Food and Drug Administration (FDA) on June 1, 2023.

This is an FDA Class I Recall, which means that use of the product could result in serious injury or even death, the agency said.

Which Products are Affected by the Megadyne Electrode Recall?

Product names and codes included in this recall:

  • MEGADYNE MEGA 2000 Patient Return Electrode 0800
  • MEGADYNE MEGA SOFT Reusable Patient Return Electrode 0830
  • MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode 0835
  • MEGADYNE MEGA SOFT Pediatric Patient Return Electrode 0840
  • MEGADYNE MEGA SOFT Universal Patient Return Electrode 0845
  • MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode 0846
  • MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode 0847
  • MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode 0848

These products were distributed between March 11, 2021, and May 9, 2023.

What is a Megadyne Electrode?

Megadyne Patient Return Electrodes are soft pads used on adults and children undergoing electrosurgery, in which an electric current is used to heat or cut tissue or to stop bleeding.

The electric current is produced by an electrosurgical generator and delivered to the tissue with a small pen-like attachment. A return electrode pad contacts the skin of the patient and conducts the electric current from the patient’s tissue back to the generator to reduce the risk of excessive heating.

A return electrode burn will occur if the heat produced is not safely dissipated by the size or conductivity of the patient return electrode.

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The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Megadyne Electrode Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

Again, if you or a loved one was injured by a Megadyne Soft Reusable Patient Return Electrode, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

References:

  1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadynetm-initiates-global-discontinuation-and-voluntary-recall-mega-softtm-pediatric-patient
  2. https://www.fda.gov/medical-devices/medical-device-recalls/megadyne-recalls-mega-2000-and-mega-soft-reusable-patient-return-electrodes-risk-serious-burn

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