More than 60 burn injuries have been reported in connection to electrosurgical pads made by Megadyne, a medical device company owned by Johnson & Johnson's Ethicon division, the FDA said July 11. No products are pulled from the market, a company spokesperson said.
The safety notification includes 21,000 MEGA 2000 and seven MEGA SOFT products, which are pads used during electrosurgery to return an electric current from a patient's skin to a generator. The pads are indicated to reduce the risk of excessive heating.
Both pediatric and adult patients have received burn injuries, and the burns "may be as serious as third-degree burns requiring medical intervention and may lead to a longer hospital stay, scarring, and potentially more surgeries," the FDA said.
As of July 11, no design or manufacturing defects have been identified, a spokesperson told Becker's.
"During an investigation into reports of patient burns identified after surgical procedures in which Mega Soft pads were one of the devices used, it was determined that in some instances, the Mega Soft pad instructions for use were not being properly followed," the spokesperson said. "In collaboration with the [FDA], we issued a notification to healthcare professionals who have purchased Mega Soft pads. The notification emphasized the importance of following the instructions for use, including proper cleaning and setup to help reduce the potential for a burn."