Cincinnati, OH – February 29, 2024 – On December 8, 2023, Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA SOFT pads were used. These reports of patient burn injuries described up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.
Since that notification, we have continued to monitor device performance through post market surveillance, investigated every event reported and evaluated potential root cause of these events. Megadyne recently received a report of pediatric use that included a serious 3rd degree patient burn. We are providing this additional broad public communication to increase awareness that MEGADYNE™ MEGA SOFT™ Universal and Universal Plus products should not be used for patients under the age of 12 years.
The table below contains the specific product and codes in scope. The following product codes should not be used for patients that are neonatal, infant, and children under the age of 12 years old:
| Product Name | Product Code | UDI-DI |
| MEGADYNE™ MEGA SOFT™ Universal Patient Return Electrode | 0845 | 10614559103906 |
| MEGADYNE™ MEGA SOFT™ Universal Dual Patient Return Electrode | 0846 | 10614559104248 |
| MEGADYNE™ MEGA SOFT™ Universal Plus Patient Return Electrode | 0847 | 10614559104842 |
| MEGADYNE™ MEGA SOFT™ Universal Plus Dual Patient Return Electrode | 0848 | 10614559104859 |
What to do
Customers should review and follow the instructions provided in the December 2023 recall notification. Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes pads may continue to be used for patients over 12 years of age.
A link to the customer notification can be found here.
Confirm that personnel using the Mega Soft Universal and Universal Plus pads understand the intended use is changing to patients aged 12 years and older and have stopped using the pads on patients under the age of 12 years. Hospitals using this product should confirm receipt of the recall notification using the business reply form provided with the initial recall notification.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: here
Regular Mail or Fax: Download form here or call 1-800-332-1088
to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
If you need additional copies of the recall notification or need a business reply form, please contact Sedgwick at 888-843-0254 and reference Event # 5627.
The safe and effective use of our products is top priority. If you have additional questions regarding this communication or to report any product complaints, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.
If medical engagement is requested, please have the Healthcare Provider submit the request using the Medical Information Request website: here