Our MegaDyne lawsuit lawyers can help if you or a loved one suffered burns after undergoing an electrosurgical procedure using MegaDyne Mega 2000 or Mega Soft Patient Return Electrodes.
MegaDyne has initiated four voluntary recalls since June 2023. Reports have indicated that pediatric and adult parents, as well as healthcare providers, have experienced burn injuries. In some cases, people experienced burns that required medical attention and treatment.
If you suffered burns during an electrosurgical procedure, you may be eligible to file a lawsuit. Our defective medical device attorneys can help you demand justice.
- What are MegaDyne Patient Return Electrodes?
- Why Were MegaDyne Products Were Recalled?
- Who Manufactures MegaDyne Patient Return Electrodes?
- Have There Been Any MegaDyne Settlements?
What are MegaDyne Patient Return Electrodes?
MegaDyne Mega Soft and Mega 2000 are soft pads used during electrosurgery. In electrosurgery, an electric current is used to heat or cut tissue or to stop bleeding. The current is generated 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 during use and conducts the electric current from the tissue back to the electrosurgical generator.
Why Were MegaDyne Products Were Recalled?
MegaDyne voluntarily recalled of some of its electrode products in June 2023 after receiving reports of patients receiving burn injuries from use. Some of the burns were as serious as third-degree burns requiring medical intervention, potentially leading to scarring and more surgeries.
According to the U.S. Food & Drug Administration (FDA) the Mega Soft reusable patient return electrode is a Class I recall, which is the most serious type of recall because the product can cause serious injuries or even death.
The FDA then published a letter to healthcare providers raising awareness over the safe use of some MegaDyne products, and to follow these safety instructions:
- Do not use Mega Soft Pediatric Return Electrodes (product code 084) in any age group
- Only use Mega 2000 and Mega Soft Patient Return Electrodes (product codes 0800, 0830, 0835, 0845, 0846, 0847, 0848) on patients 12 years and older.
- Monitor patients post-operatively after procedures using Mega 2000 and Mega Soft pads.
The patient return electrode devices were distributed between March 11, 2021 and May, 9 2023. Over 21,000 electrode devices have been recalled. The medical device recall from 2023 includes the following products and names:
- MegaDyne Mega 2000 Patient Return Electrode 0800
- MegaDyne Mega Soft Reusable Patient Return Electrode 0830
- MegaDyne Mega Soft 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
MegaDyne voluntarily initiated the global discontinuation and voluntary recall of Mega Soft Pediatric Patient Return Electrode in May 2024.
Who Manufactures MegaDyne Patient Return Electrodes?
MegaDyne Medical Products, Inc. was bought by Ethicon, Inc., a Johnson & Johnson MedTech subsidiary in 2017.
Ethicon, Inc. has manufactured surgical sutures and wound closure devices since 1887. Ethicon also manufactures physiomesh, which has its own class-action lawsuits pending.
Have There Been Any MegaDyne Settlements?
The litigation against the pharmaceutical company is so new there are no settlements yet, however, there are hundreds of cases currently being reviewed. For most drug manufacturer lawsuits, the cases can take several years before there are any compensation payout amount determinations.
When it gets to that stage of litigation, there is a specific claim submission process. Every MegaDyne lawsuit claimant will submit a claim detailing their injuries and side effects. The claimants with more serious injuries will receive higher settlements.
Contact a MegaDyne Lawyer Today
If you or someone you care about suffered burns after undergoing an electrosurgical procedure using MegaDyne Mega 2000 or Mega Soft Patient Return Electrodes, you may benefit from speaking with a defective medical device attorney.
To be eligible for a lawsuit, you must meet the following criteria:
- You or your loved one underwent a procedure involving electrosurgery between March 11, 2021 and July 31, 2024
- A MegaDyne Patient Return Electrode device was used
- You or your loved one sustained second or third-degree burns
Contact Buckfire Law for a free case review. We charge no fees unless we win.
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