Megadyne Mega Soft Patient Return Electrode

Issue

Megadyne Medical Products, Inc. (“Megadyne”) has received reports of patient burns identified after surgical procedures in which Mega Soft pads were used. Megadyne is aware of 63 complaints of serious patient burns globally since April 2018. Megadyne has conducted a thorough investigation, and to this point have not identified any design or manufacturing defects, nor determined definitive root cause. However, Megadyne has determined that in some instances the Mega Soft pad Instructions for Use (IFU) were not being properly followed. Recall start date: June 6, 2023

What you should do

• Contact the manufacturer if you require additional information.