Following a May recall of electrode pads, Megadyne has issued correction instructions for three of its electrode products to prevent burn injuries to pediatric patients.
The company instructs providers to not use Mega Soft, Mega Soft Dual and Mega 2000 patient return electrodes for patients under age 12, and to follow proper cleaning, placement and setup steps before continuing to use the products on older children.
A notice on the Food and Drug Administration (FDA) website says Megadyne issued the correction after 15 reported injuries associated with Mega Soft and Mega 2000 electrodes.
“The use of affected product may cause serious adverse health consequences for patients, including third-degree burns, scarring and additional surgeries,” the FDA said. There have been no reported deaths associated with the products.
The electrode pads are used to conduct electric current from the patient’s tissue during electrosurgery and are designed to reduce the risk of excessive heating of the patient’s tissue.
The FDA categorizes this correction as a Class I recall, its most serious type, but does not call for the removal of the electrode pads from practices and merchants.
The affected devices carry the following unique device identifiers and product codes:
- Mega 2000 patient return electrode: 10614559100936, 0800
- Mega Soft reusable patient return electrode: 10614559101797, 0830
- Mega Soft Dual reusable patient return electrode: 10614559101872, 0835
Questions should be directed to the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). Health care providers and consumers can report adverse reactions to the FDA’s MedWatch system.
