Dive Brief:
- J&J has limited the use of three models of Megadyne patient return electrodes due to the risk of burns.
- In a June recall notice, the company said the reusable patient return electrodes should only be used in people ages 12 and older. J&J took a similar action late last year when it limited the use of four other electrode products.
- The Food and Drug Administration said in a Thursday notice that there have been 15 reported injuries related to the problem. The agency labeled the recall as Class I, its most severe classification.
Dive Insight:
J&J’s Mega Soft patient return electrodes are used to protect people during electrosurgery. The pads are placed on a patient’s skin to conduct electric currents from their tissue back to the generator to reduce the risk of excessive heating.
The devices had been authorized for use in patients over 25 lbs, but J&J changed the instructions to limit the products to people 12 years and older after receiving reports of burn injuries. The new instructions apply to its Mega 2000, Mega Soft reusable and Mega Soft dual reusable patient return electrodes.
In a letter to customers, the company said it received reports of patient burn injuries “up to and including third-degree burns” associated with use of Mega Soft pads. J&J said it did not identify any design or manufacturing defects in an investigation of the problem.
J&J warned about the potential for burns in a letter sent to customers in June 2023. At the time, the company said it had received 63 complaints of serious burns globally since April 2018. J&J said in its latest safety notice that there have been no reported burn injuries for patients under age 12 since that letter was distributed.
In December, J&J restricted the use of four other electrode pads to people ages 12 and older for similar reasons. The company also discontinued a patient return electrode pad designed for pediatric patients in May because of the risk of burns.
