Megadyne Pad Recall: FDA Class I Alert for Pediatric Safety

by | Jun 20, 2024 | Product Liability, Medical Devices | 0 comments

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Has your child been injured during surgery? Is it due to the Megadyne Mega Soft Pediatric Electrode?

The U.S. Food and Drug Administration recently issued a Class 1 recall on Megadyne’s Mega Soft Pediatric Patient Return Electrodes, the most serious type of recall issued by the FDA. The recall of these products could lead to severe health risks, including serious injuries or death.

Let’s take a closer look at why this Megadyne Pad recall was initiated, what it involves, and the steps that medical facilities need to take to ensure patient safety.

Megadyne Mega Soft Pediatric Electrode

Before getting into the topic, let’s learn about what a Megadyne Mega Soft Pediatric Electrode is. It is a medical device used during surgical procedures involving electrosurgical instruments. Electrosurgery is a common medical procedure where an electric current is used to cut tissue, heat tissue, or stop bleeding. This current is generated by an electrosurgical generator and delivered to the tissue through a pen-like attachment.

The Megadyne Mega Soft Pediatric Electrode is a soft pad designed for children who weigh between 0.8 and 50 pounds. The pad provides a safe path for electrical currents used in surgery, helping to prevent electrical burns by ensuring the current flows safely through the patient’s body and back to the surgical equipment. The electrode is soft, flexible, reusable, comfortable, and cost-effective for pediatric use.

Designed for use during electrosurgical procedures, these devices cause burn injuries, leading to immediate harm and preventing further harm.

Megadyne Mega Soft Pediatric Electrode Recall

On May 10, 2024, Megadyne recalled all Mega Soft pediatric patient return electrodes due to reports of burn injuries in children. Testing showed that certain conditions can cause these injuries, especially in infants and small children.

There have been four reported injuries since 2018. Due to this issue, the company has decided to stop selling this product and has recalled it. The affected product can be identified by the code 0840 and the name “Pediatric Return Electrode Pad.”

The product was sold in the U.S. and internationally. The company asked the customers to stop using the product and return it. However, despite their intended safety benefits, the reports of burn injuries have highlighted a significant risk when using these electrodes with pediatric patients.

Reasons behind the Megadyne Pad Recall

The recall of the Mega Soft Pediatric Patient Return Electrodes was initiated following reports of burn injuries in pediatric patients. The FDA emphasized the seriousness of this Megadyne pad recall by classifying it as Class I. Megadyne received reports of four injuries where these electrodes caused burn injuries, including severe third-degree burns that required additional surgeries and could lead to scarring.

There have been no reports of death associated with these injuries, but the potential for such serious harm prompted the company to take immediate action.

Megadyne’s recall involves the removal of the affected Mega Soft Pediatric Patient Return Electrodes from all healthcare facilities and locations where they are used or sold. Adverse reactions or quality problems can be reported to the FDA’s MedWatch program.

The company sent out an ‘Urgent Medical Device Recall’ letter for removal on May 8, urging all healthcare providers and facilities to stop using the affected devices immediately and to return them to the company by August 31, 2024, to receive credit reimbursement.

MEGA 2000 and MEGA Soft Reusable Electrodes Recall

Megadyne initiated a MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes recall on June 1, 2023, after receiving 63 injury reports, though no deaths have been reported. The recalled products include:

  • MEGA 2000 (Product Code: 0800)
  • MEGA SOFT Reusable (Product Code: 0830)
  • MEGA SOFT Dual Reusable (Product Code: 0835)
  • MEGA SOFT Pediatric (Product Code: 0840)
  • MEGA SOFT Universal (Product Code: 0845)
  • MEGA SOFT Universal Dual (Product Code: 0846)
  • MEGA SOFT Universal Plus (Product Code: 0847)
  • MEGA SOFT Universal Plus Dual (Product Code: 0848)

These devices were distributed between March 11, 2021, and May 9, 2023. The Megadyne pad recall was a voluntary correction rather than a product removal. Medical professionals were advised to monitor patients post-surgery as well.

Megadyne Mega Soft Universal Patient Return Electrode Recall

On March 1, 2023, the FDA issued a reminder to health care facilities to avoid using some of the Megadyne products on patients under 12 years old. This recall was categorized as a Class 1 recall and addressed a correction rather than a product removal due to the risk of serious injuries or death.

The affected products include:

  • Megadyne Mega Soft Universal
  • Megadyne Mega Soft Universal Dual
  • Megadyne Mega Soft Universal Plus
  • Megadyne Mega Soft Universal Plus Dual

These devices were distributed between October 1, 2021, and December 4, 2023. Megadyne initiated the recall on December 8, 2023, to update the device instructions and labels, restricting use to patients aged 12 and older after receiving 99 reports of burn injuries, although no deaths have been reported.

To conclude,

If you or your child have been affected by Megadyne products, contact a skilled lawyer to file a Megadyne pad lawsuit.

Patients and their families rely on the safety of medical devices used during surgeries, and medical professionals have a responsibility to ensure that they are using safe and effective equipment. It’s important to take action to protect your rights and seek compensation for any harm caused.

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Luis

Medlegal 360

MedLegal360 is a specialized author in medical-legal matters, providing clear, authoritative insights on healthcare legislation and personal injury litigation for professionals and the curious.

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