The FDA is informing consumers that four devices are included in Megadyne Medical Product, Inc.’s recall of Mega Soft Universal Patient Return Electrodes because the Instructions for Use and product labeling need to be updated to restrict device use to patients aged 12 and older.
Identified as Class I, the most serious type, because of the risk of serious injuries or death posed to patients, the recall was first announced on December 8, 2023, and covers 9,428 devices that were distributed in the U.S. between October 1, 2021, and December 4, 2023. The following four products, listed with their model numbers, are affected:
- Megadyne Mega Soft Universal
- Model Number 0845
- Megadyne Mega Soft Universal Dual
- Model Number 0846
- Megadyne Mega Soft Universal Plus
- Model Number 0847
- Megadyne Mega Soft Universal Plus Dual
- Model Number 0848
Used during surgeries that require the use of electrosurgical instruments, the Mega Soft Universal Patient Return Electrode is used as an important safety measure to protect patients from electrical injury. It helps ensure that the electrical current flows safely through a patient’s body and makes a safe return path to the electrosurgical unit. The electrode is designed to minimize electrical burn risks, as well as prevent electrical energy from concentrating in a single area of the patient’s body.
At the time of the FDA update posted on July 31, 2024, Megadyne has been alerted to reports of 99 related patient burn injuries, including third-degree burns that necessitated medical intervention. In both pediatric and adult patients, burn injuries may result in a range of outcomes depending on the severity: “extended hospital stay, scarring, and additional surgeries,” as well as other longer-lasting conditions that have a higher likelihood of affected patients younger than age 12.
No deaths in connection to the recall have been reported.
Consumers and healthcare providers should note that while the device’s current Instructions for Use may still be followed, the instructions now apply only to patients 12 years of age and older.
The original medical device correction notice sent out to all Megadyne Medical Products, Inc. customers on December 8, 2023 made the following requests:
- Confirm that all users of Mega Soft Universal and Universal Plus pads are notified that the intended use of the devices has now been updated to serve only patients aged 12 years and older.
- Ensure that a copy of the alert is posted visibly as a reminder to staff that the devices should not be used on patients younger than 12 years of age.
- If “medical engagement” with the manufacturer is needed, reach out to Ethicon Resource Department by calling 1-877-ETHICON (1-877-384-4266).
- Within the next three business days, complete and submit the Business Reply Form via fax or email to Sedgwick.
- Heed the instructions for the “proper cleaning, placement, and setup” of the Mega Soft pad.
As the FDA continues to oversee this recall, healthcare professionals and consumers are asked to report any related adverse experiences or quality issues to the agency’s MedWatch program.
Have you or a loved one suffered a burn injury or another adverse health outcome due to the improper administration of a medical device? We encourage you to seek out trusted legal support and representation as soon as possible. Our compassionate attorneys at TruLaw would like to learn about your case and help you build a case for the compensation you deserve. We are personally invested in holding negligent parties responsible and fighting to secure the funds you need for the best recovery. To learn more, contact us today or take our free Instant Case Evaluation ℠ .