Dive Brief:
- Johnson & Johnson’s Megadyne business has discontinued a pediatric electrode pad after receiving reports of patients being burned during procedures where the device was used.
- The electrode pad is included in a line of products that were part of a Megadyne recall in December. At that time, the J&J unit restricted the use of four products in patients under the age of 12, but it did not change instructions for one device designed for people who weigh 0.8 to 50 pounds.
- J&J, which announced the recall Friday, is discontinuing the product indicated for use in people weighing up to 50 pounds after tests on the causes of four reported injuries found a combination of factors that could result in burns.
Dive Insight:
Physicians use Megadyne Mega Soft electrode pads to prevent the risk of burns in procedures that use electrosurgical instruments. When the devices are in place, currents should flow through the patient and back to the electrosurgical unit. The system prevents electrical energy from building up in one part of the body and burning the patient.
However, Megadyne received reports of 99 injuries, including third-degree burns requiring intervention, inflicted during procedures featuring four Mega Soft products, according to the Food and Drug Administration’s January recall notice. The reports led the J&J unit to restrict the use of the four products to people aged 12 years and older.
Megadyne has now expanded the recall after tests showed the conditions that may result in burns are more likely to be found when the pad is used with infants and small children.
That finding is particularly important for the Mega Soft product indicated for use in people who weigh up to 50 pounds.
“Because the pediatric pad is designed for patients between 0.8 to 50 pounds, which would be predominantly patients under the age of 12, the decision was made to discontinue and recall the 0840 pediatric pad product,” the company said.
Megadyne is writing to customers to arrange the return of the affected products, which it distributed in the U.S. and overseas.
The company has notified the FDA of the action.
