Megadyne is recalling MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes after receiving reports of patient burn injuries in procedures where the MEGA SOFT Pediatric Patient Return Electrodes were used.
The use of affected product may cause serious adverse health consequences for pediatric patients, including third-degree burns, scarring, and additional surgeries.
There have been four reported injuries. There have been no reports of death.
MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes are soft pads used during electrosurgery for children who weigh between 0.8 and 50 lbs. In electrosurgery, an electric current is used to heat or cut tissue or to stop bleeding. The electric current is generated by an electrosurgical generator and delivered to the tissue with a small pen-like attachment. A return electrode pad contacts the skin of the laying patient during use and conducts the electric current from the patient’s tissue back to the electrosurgical unit, or generator, to reduce the risk of excessive heating.
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