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Published by Free Confidential Megadyne Electrode Lawsuit Review
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 compensation by filing a Patient Return Electrode Lawsuit and our lawyers can help. Please click the button below for a Free Confidential Case Evaluation or call us toll-free 24 hrs/day by dialing (866) 588-0600.
Megadyne Medical Products, Inc. has announced a Class I recall, the most serious designation by the FDA, for over 21,000 patient return electrodes following reports of severe burn injuries in both pediatric and adult patients.
The affected devices have been linked to third-degree burns, posing significant medical risks and raising concerns over patient safety in surgical procedures.
With regulatory bodies classifying this recall at the highest risk level, healthcare providers and facilities must take immediate action to remove these devices from use to prevent further harm.
If you or a loved one has suffered burns or other injuries due to a recalled Megadyne electrode, legal options may be available.
Read on to learn more about the affected devices, safety risks, and what steps to take. Schmidt & Clark’s experienced attorneys are ready to assist those impacted by this recall, helping victims seek compensation and hold negligent manufacturers accountable.
Table Of Contents
- Quick Summary:
- Megadyne Electrodes Recalled Over Burn Injury Risk to Children
- Which Products are Affected by the Megadyne Electrode Recall?
- FDA Issues Warning on Serious Burn Injuries Linked to Megadyne Patient Return Electrodes
- Filing a Lawsuit for Megadyne Electrode Injuries: What You Need to Know
- How to Build a Strong Megadyne Electrode Lawsuit: Key Steps for Success
- FAQs
- Get a Free Megadyne Electrode Lawsuit Evaluation With Our Lawyers
Quick Summary:
- Pediatric patients under 12 face a high risk of third-degree burns, leading to restricted use and a full recall of certain electrode models, while adults have also reported 99 burn injuries.
- Over 21,000 units of Megadyne’s Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes have been recalled due to serious safety concerns.
- The FDA classified this as a Class I recall, the most serious category, indicating a high risk of severe injury if the devices remain in use.
- Key recall actions include the announcement of affected models on December 8, 2023, the discontinuation of the Pediatric Patient Return Electrode on May 20, 2024, and updated safety labeling on July 10, 2024.
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].
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.
Which Products are Affected by the Megadyne Electrode Recall?
Megadyne Medical Products has issued a Class I recall for multiple patient return electrodes due to serious burn injury risks.
If you or your healthcare facility uses Megadyne electrodes, check the list below to see if your device is affected:
| Product Name | Product Code |
|---|---|
| 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 (Discontinued & Recalled) | 0840 (FDJ3091) |
| 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 |
Distribution Details: Are You Using a Recalled Device?
- Distribution Period: March 11, 2012 – May 9, 2023
- Age Restriction Alert: The Mega Soft Universal electrodes are restricted to patients aged 12 and older due to serious safety concerns.
Important Safety Updates
- The Mega Soft Pediatric electrode has been globally discontinued and recalled due to an increased risk of third-degree burns.
- Users should check product codes and follow updated safety guidelines to ensure compliance with the recall.
If you or your healthcare facility is using any of these products, discontinue use immediately and follow recall procedures to prevent potential injuries.
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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FDA Issues Warning on Serious Burn Injuries Linked to Megadyne Patient Return Electrodes
On June 1, 2023, the U.S. Food and Drug Administration (FDA) issued a Class I recall notice for Megadyne Patient Return Electrodes due to reports of severe burn injuries, including third-degree burns in both pediatric and adult patients.
According to the recall, these burns may require prolonged hospitalization, surgical interventions, and may lead to permanent scarring or disability [2].
The recall was triggered by at least 99 reported burn injuries linked to Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes.
While no fatalities have been confirmed, third-degree burns are considered life-threatening injuries that can lead to long-term complications, infections, and additional surgeries.
Key Findings from the FDA Recall Notice
The FDA recall of Megadyne Patient Return Electrodes highlights the serious risks associated with these devices, particularly the potential for severe burn injuries.
The following key points outline the most critical safety concerns identified in the recall:
- Burn Severity: Many reported burns were full-thickness (third-degree) burns, which destroy all skin layers and damage underlying tissues.
- Pediatric Risk: Due to an increased risk of severe burns, certain Megadyne electrode models were completely discontinued for children under 12 years old.
- Long-Term Health Impact: Patients affected by burns may suffer from extensive scarring, nerve damage, mobility limitations, and chronic pain.
- Medical Costs: Severe burns often result in high medical expenses, including multiple surgeries, extended hospital stays, and rehabilitation.
These findings underscore the importance of patient safety and regulatory action in preventing further harm.
If you or a loved one has suffered burn injuries due to a Megadyne Patient Return Electrode, seeking legal guidance may help you secure compensation for medical costs and other damages.
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.
Filing a Lawsuit for Megadyne Electrode Injuries: What You Need to Know
If you or a loved one has suffered severe burns or other injuries due to a recalled Megadyne patient return electrode, you may be eligible to file a lawsuit against the manufacturer.
Holding Megadyne Medical Products, Inc. accountable can help recover financial compensation for medical bills, lost wages, and pain and suffering.
Below, we break down the critical legal information regarding these lawsuits, including compensation eligibility, legal deadlines, and the steps required to take legal action.
Statute of Limitations: When to File a Claim
Time is limited when it comes to filing a lawsuit. The statute of limitations varies by state, meaning injured patients must act quickly to avoid missing the legal deadline.
In many cases, the timeframe to file a product liability lawsuit ranges from two to four years from the date of injury or discovery of harm.
Consulting an experienced attorney as soon as possible ensures your claim is filed within the correct legal window and protects your right to seek compensation.
Compensation Available for Victims
Those affected by Megadyne electrode burns may be eligible for financial compensation that covers the full extent of damages caused by the defective device.
Compensation in these lawsuits may include:
- Medical Expenses: Covers past, present, and future medical costs related to treating burn injuries, including surgeries, hospitalizations, and physical therapy.
- Lost Wages: Victims unable to work due to injury-related recovery time can seek compensation for lost income.
- Pain and Suffering: Severe burns often result in long-term pain, emotional distress, and reduced quality of life, which can be factored into a settlement.
- Punitive Damages: If gross negligence by Megadyne is proven, courts may award additional punitive damages to punish the company and deter future misconduct.
The extent of these damages can significantly impact the overall compensation amount, as courts consider both the physical and emotional toll on the victim.
Understanding the types of damages available can help strengthen your claim and ensure you seek the full compensation you deserve.
Types of Damages You Can Claim
The severity of your injury plays a crucial role in determining the compensation amount you may be entitled to receive.
Patients who suffered the following complications may have a stronger case:
- Severe Burns: Second-degree and third-degree burns requiring skin grafts or reconstructive surgery.
- Scarring and Disfigurement: Long-term visible damage caused by deep burns or surgical intervention.
- Additional Surgeries: Some victims require corrective surgeries to repair tissue damage.
- Emotional Distress: The trauma of burn injuries can lead to depression, anxiety, and PTSD, all of which may be compensable under the law.
Settlement Outlook: What to Expect
As of September 2024, there have been no publicly reported settlements or jury verdicts in lawsuits against Megadyne.
These cases are still in their early stages, but similar product liability lawsuits involving defective medical devices have resulted in substantial compensation for injured patients.
Settlement amounts often depend on:
- The extent of injuries suffered
- Medical costs and ongoing treatment needs
- The strength of evidence proving the device caused harm
- Whether the lawsuit is part of a larger Multi-District Litigation (MDL)
While no exact payout figures are available yet, past cases involving medical device recalls suggest potentially significant compensation once lawsuits progress.
Steps to File a Lawsuit Against Megadyne
If you believe you or a family member has been harmed by a Megadyne patient return electrode, following these steps can help strengthen your case:
- Consult a Product Liability Attorney: Seek legal guidance from an experienced medical device injury lawyer to evaluate your claim.
- Gather Medical Records: Collect surgical reports, burn treatment records, and hospital documentation proving the extent of your injuries.
- Obtain Proof of Electrode Use: If possible, locate medical device logs, hospital records, or witness statements showing the electrode was used during your procedure.
- File a Legal Complaint: Your attorney will draft and file your lawsuit, detailing how Megadyne’s defective product caused your injuries.
- Consider Multi-District Litigation (MDL): If multiple lawsuits are filed, cases may be consolidated into an MDL, which can help streamline legal proceedings but may impact individual compensation amounts.
How to Build a Strong Megadyne Electrode Lawsuit: Key Steps for Success
Filing a lawsuit against Megadyne Medical Products requires a well-documented legal strategy backed by solid evidence and expert analysis.
Plaintiffs must demonstrate that the defective patient return electrodes directly caused severe burn injuries or other complications.
Understanding the legal process, necessary documentation, and expert testimony is essential to building a strong case.
Gathering the Right Evidence
A successful lawsuit depends on collecting comprehensive evidence that clearly links the injuries sustained to the use of a Megadyne electrode.
Essential documentation includes:
- Medical Records: Detailed reports confirming the injuries sustained, surgeries performed, and any ongoing treatments.
- Device Usage Proof: Hospital or surgical records verifying that a Megadyne electrode was used during the procedure.
- Incident Reports: Reports filed by healthcare facilities acknowledging the device’s malfunction or safety risks.
- Expert Testimony: Medical device specialists or electrosurgery experts who can confirm design flaws or malfunction risks associated with Megadyne electrodes.
Why Expert Testimony Matters
Based on our experience in defective medical device lawsuits, expert testimony is critical for proving that the injury resulted directly from the product’s malfunction or unsafe design.
Experts provide insights into:
- Manufacturing & Design Defects: Identifying how Megadyne electrodes failed safety standards or quality control measures.
- Industry Standards: Comparing Megadyne’s safety protocols to FDA-approved guidelines for medical device safety.
- Injury Causation: Explaining how burn injuries and other complications are consistent with electrode malfunctions.
The Role of Medical Documentation
Medical records serve as foundational evidence in any product liability case.
They must clearly outline:
- The exact nature of the injuries (e.g., second-degree or third-degree burns, infections, or scarring).
- The immediate and long-term medical impact, including any corrective surgeries or rehabilitation.
- The pain, suffering, and reduced quality of life caused by the injury.
Legal Process Timeline: What to Expect
Filing a Megadyne lawsuit involves multiple legal phases, each requiring careful preparation and legal representation.
-
Initial Consultation: Meet with a product liability attorney to evaluate the viability of your claim.
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Evidence Collection: Gather all medical records, hospital reports, and expert analyses to support your case.
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Filing the Lawsuit: File your claim within the statute of limitations to avoid losing your right to compensation.
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Discovery Phase: Exchange evidence with Megadyne’s legal team; depositions may be conducted with key witnesses.
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Settlement Negotiations: Many defective medical device cases settle before trial, but negotiations depend on evidence strength and injury severity.
-
Trial Preparation & Verdict: If a settlement isn’t reached, your attorney will present evidence in court, and a jury will determine liability and compensation.
If you or a loved one suffered severe burns or other injuries due to a Megadyne electrode, it is crucial to act quickly.
An experienced defective medical device attorney can help navigate the legal process, gather critical evidence, and fight for maximum compensation.
FAQs
Why might there be a lawsuit related to the Megadyne Electrode?
A lawsuit might arise if the Megadyne Electrode is found to be defective or if its use results in serious injuries to patients. Issues such as manufacturing defects, design flaws, or inadequate instructions could lead to legal action against the manufacturer.
What should I do if I’ve been injured by a Megadyne Electrode during surgery?
If you’ve been injured, seek medical attention immediately to address any complications. Afterward, consult with an attorney who specializes in medical device litigation to explore your legal options, including potential compensation for your injuries.
Can I file a lawsuit if a loved one died due to complications from a Megadyne Electrode?
Yes, if a loved one died due to complications from a Megadyne Electrode, you may be eligible to file a wrongful death lawsuit. This type of lawsuit seeks compensation for the loss of your loved one, including funeral expenses and loss of companionship.
What evidence is needed to support a lawsuit involving the Megadyne Electrode?
Evidence may include medical records documenting the injury, expert testimony linking the device to the harm caused, and any documentation showing that the device was defective or used improperly during surgery.
See all related medical device lawsuits our attorneys covered so far.
Get a Free Megadyne Electrode Lawsuit Evaluation With Our Lawyers
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:
- https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadynetm-initiates-global-discontinuation-and-voluntary-recall-mega-softtm-pediatric-patient
- https://www.fda.gov/medical-devices/medical-device-recalls/megadyne-recalls-mega-2000-and-mega-soft-reusable-patient-return-electrodes-risk-serious-burn