Recall Issued for Megadyne Mega Soft Universal Pads Over Patient Burn Concerns

Recall Issued for Megadyne Mega Soft Universal Pads Over Patient Burn Concerns

Recall Issued for Megadyne Mega Soft Universal Pads Over Patient Burn Concerns

UPDATES:

Megadyne has informed both new and existing customers in a letter issued in September 2024 that the affected devices should only be utilized for patients aged 12 years and above. Moreover, the eIFU of these devices notes that no materials are to be placed between the patient and the Mega Soft pad (such as sheets).

The devices specified below are part of the FDA’s “Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes – Letter to Health Care Providers” dated July 31, 2024.

The FDA advises healthcare facilities and their personnel not to use the Mega Soft Universal and Mega Soft Universal Plus for patients younger than 12 years old.

Please note that this recall is categorized as a correction rather than a product withdrawal.

This recall has been classified by the FDA as a Class I recall, the most severe type. Using these devices may result in serious injuries or even death.

Recalled Product 

  • Product Names: Megadyne Mega Soft Universal, Megadyne Mega Soft Universal Dual, Megadyne Mega Soft Universal Plus & Megadyne Mega Soft Universal Plus Dual 
  • Product Codes: GEI
  • Model Numbers: 0845, 0846, 0847, 0848
  • Distribution Dates: October 1, 2021, to December 4, 2023 
  • Devices Recalled in the U.S.: 9428
  • Recall Initiated by Firm: December 8, 2023

Device Use 

The Mega Soft Universal Patient Return Electrode serves as a medical device employed in surgeries utilizing electrosurgical instruments. Its design aims to secure the patient’s safety by offering a secure return pathway for the electrical current during these operations.

The primary function of the electrode is to reduce the risk of electrical burns by ensuring safe current flow through the patient’s body back to the electrosurgical unit, preventing the accumulation of electrical energy in a single area. It acts as a vital safety measure during electrosurgery, protecting the patient from potential electrical injuries.

Reason for Recall 

Megadyne Medical Product, Inc. is executing a recall of the Mega Soft Universal Patient Return Electrodes to revise the Instructions for Use and product labeling, restricting the device’s usage to patients aged 12 years and older.

Reports of patient burn injuries have prompted this action, including third-degree burns requiring medical intervention. Such burn injuries may extend hospital stays, cause scarring, and necessitate additional surgical procedures, particularly for pediatric patients. Serious burns could have lasting effects, especially in those aged under 12 years.

Users must adhere to the current Mega Soft Instructions for Use, except for the newly defined demographic limitations.

There have been a total of 99 reported injuries, with no fatalities reported.

Who May be Affected 

  • Adults and children undergoing electrosurgery that involve MEGA SOFT Universal Reusable Patient Return Electrodes. This product is not intended for use in children aged 12 years or younger.
  • Healthcare providers employing Megadyne Mega Soft Universal Patient Return Electrodes for monopolar electrosurgery or caring for patients post-surgery involving these electrodes.

What to Do 

On December 8, 2023, Megadyne Medical Products, Inc. distributed an URGENT medical device correction notice to all affected customers.

The letter requested that customers take the following actions:

  • Communicate this information with all users of Mega Soft Universal and Universal Plus pads and verify with them that the intended use has changed to patients aged 12 years and older.
  • Display a copy of this communication prominently to remind staff about the new usage guidelines.
  • Reach out to the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266) for any necessary medical engagement with the manufacturer.
  • Complete and return the Business Reply Form included with the letter to Sedgwick within three business days.
  • Adhere to proper procedures for cleaning, placement, and setup of the Mega Soft pad.

Contact Information 

Customers in the U.S. with inquiries concerning this recall can contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).

Additional Resources: 

How do I report a problem? 

Healthcare professionals and consumers can report adverse reactions or quality issues experienced with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program via an online form, by mail, or by FAX.