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Johnson & Johnson's Megadyne business has ceased production of a pediatric electrode pad due to reports of patient burns during procedures. Initially part of a December recall affecting four products restricted for patients under 12, the company continued to allow use of one device for those weighing 0.8 to 50 pounds. However, after tests linked four injuries to factors causing burns, J&J announced the discontinuation.
Megadyne's Mega Soft electrode pads are used to prevent burns in procedures involving electrosurgical instruments by directing currents through patients. Despite this, the FDA reported 99 injuries, including third-degree burns, from four Mega Soft products, leading to the initial age restriction. Subsequent tests revealed an increased burn risk in infants and small children, prompting the global discontinuation. Megadyne is facilitating the return of affected products, distributed both domestically and internationally, and has notified the FDA.
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