A Class I Medical Device Correction (MDC) sent to hospitals on December 8, 2023, regarding the intended use of Megadyne’s Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes was revised by Megadyne on February 29, 2024, according to the FDA.
Officials said that after receiving reports of burns in both adult and pediatric patients after surgical procedures involving the use of Mega Soft pads, the MDC was issued to limit the use of the product to patients 12 year of age or older. The reports detailed a range of injuries which included third-degree burns that required medical intervention. Those interventions could then potentially result in “prolonged hospital stay, scarring, and additional surgeries” for pediatric and adult patients alike. Consumers should note that patients, particularly those under age 12, could suffer severe burns that stand to leave long-term health consequences.
Following the initial announcement of the product correction, the FDA used post-market surveillance to continue evaluating the performance of the devices. The agency also investigated every reported event and the potential origin of each. One pediatric use case that resulted in a major 3rd-degree burn to the patient prompted the FDA to raise more awareness and remind the public that Megadyne Mega Soft Universal and Universal Plus products are not advised for patients younger than 12 years old.
All affected products, which should not be used only for neonates, infants, and children under 12-years-old, fall under all of the following product codes:
- Megadyne Mega Soft, Universal Patient Return
- product code 0845
- UDI-DI 084510614559103906
- Megadyne Mega Soft, Universal Dual Patient Return Electrode
- product code 0846, UDI 10614559104248
- UDI-DI 10614559104248
- Megadyne Mega Soft, Universal Plus Patient Return Electrode
- product code 0847
- UD-DI 10614559104842
- Megadyne Mega Soft Univeresal Plus Dual Patient Return Electrode
- product code 0848
- UDI-DI 10614559104859
Customers are advised that instructions outlined in the December 2023 recall should be followed. Patients who are over 12 years of age may continue to use the Universal Plus Reusable Patient Return Electrodes pads.
Medical professionals and hospitals should take the necessary steps to ensure that if their facility confirms receipt of the recall.
Any adverse experiences or quality issues should be reported to the FDA’s MedWatch program–either online, regular mail, or fax–using the contact information provided in the agency’s announcement.
If you or a loved one has experienced an adverse health outcome believed to be connected to the use of a compromised medical device, your family deserves fair compensation. Our experienced attorneys at TruLaw work tirelessly to safeguard consumer safety standards and hold negligent parties responsible for pain and suffering. Connect with us online or try out our free Instant Case Evaluation ℠ to learn more.