Six months after tagging a recall for Megadyne’s Mega Soft Universal Patient Return Electrode as Class I, the US Food and Drug Administration (FDA) has issued another Class I rating for the paediatric version of the device.
Class I indicates the agency’s most serious designation for a recall, meaning continued use of the products, without actions being taken, could cause serious injury or death.
A medical device subsidiary of Johnson and Johnson (J&J), Megadyne discontinued its Mega Soft and Mega 2000 paediatric return electrodes last month. The device was part of a line of products recalled in July 2023, and later expanded in December 2023.
The flat and reusable pads are placed on the skin of the patient undergoing electrosurgery to help dissipate excessive heating, conducting the electric current from the patient back to the generator or electrosurgical unit. The paediatric version is for use on children who weigh between 0.8lb and 50lb.
The recall is due to reports of patient burn injuries whilst using the device. Health consequences include third-degree burns, scarring, and the need for additional surgeries.
There have been four injuries due to the device. No deaths have been reported.
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According to the FDA’s recall database, there are 1,270 devices currently in circulation.
In a letter to customers, Megadyne requested facilities and providers to stop using the devices. “Customers are required to immediately return all Megadyne Mega Soft Paediatric Patient Return Electrodes subject to this recall,” the FDA notice stated.
In a May statement, Magadyne said: “A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential for thermal injuries.
“The combination of these conditions may be more likely when the pad is used with infants and small children. Because the paediatric pad is designed for patients between 0.8lb to 50lb, which would be predominantly patients under the age of 12, the decision was made to discontinue and recall the 0840 paediatric pad product.”
The Mega Soft Universal and Mega Soft Universal Plus devices recalled in June 2023 saw 21,100 units affected. The December recall occurred after 99 reports of injuries. A total of 9,428 devices in the US were recalled at that point.
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- Source: https://www.medicaldevice-network.com/news/fda-tags-megadyne-paediatric-return-electrode-recall-as-class-i/
