Dive Brief:

• The Food and Drug Administration has categorized an urgent medical device correction from Johnson & Johnson’s Megadyne as a Class I event.
• Megadyne contacted customers last month to restrict the use of four electrode products in children under the age of 12 years. The products are staying on the market with a narrower label.
• The J&J unit took the action after receiving reports of burn injuries that could be particularly harmful to children. Megadyne has received reports of 99 injuries and no deaths, according to the FDA’s Monday recall notice.

Dive Insight:

The electrode pads help direct currents from certain instruments used during surgery through the patient's body to prevent the risk of energy concentrating in one area and burning the patient, according to the FDA.

Megadyne sent an urgent field safety notice about the burn risk in June, leading to a Class I notice from the FDA the next month. At that time, the company had received reports of 63 injuries linked to eight of its Mega Soft electrode products.

In its initial review, Megadyne linked some burn cases to failure of providers to follow the instructions for use but was unable to find design or manufacturing defects or confirm the root cause. 

Patients have suffered “third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring and additional surgeries in both pediatric and adult patients,” Megadyne wrote. Megadyne sees prohibiting use in children under the age of 12 years as a way to reduce the risk that burns will have “long-lasting impacts.” The change covers 9,428 devices distributed between 2021 and 2023. 

The new restrictions apply to four of the eight products covered by the first Megadyne notice and Class I recall. Three of the other four products are indicated for use in patients who weigh 25 lbs and over. The fourth product is indicated for use in people weighing 0.8 lbs to 50 lbs. The indications and instructions for use of those four products are unchanged.