MEGADYNE™, of Cincinnati, Ohio, has announced a discontinuation and voluntary recall of all of its MEGA SOFT™ Pediatric Patient Return Electrodes due to risk of burn injuries, according to the FDA.
Officials say the decision was made after a number of patients reported burn injuries while using the Mega Soft Patient Return Electrodes during procedures. The reports prompted an investigation and testing, which indicated that the thermal injuries could result from a number of combined factors.
Infants and small children under 12 years of age were identified as those most at risk because the pediatric pad is indicated for use by patients who weigh less than 50 pounds.
According to the May 10, 2024 FDA announcement, MEGADYNE™ has received 4 total reports of injuries and 0 reports of death in connection to the problem since 2018. Ever since the product removal, the company has alerted the FDA and has taken worked to alert its customers and distributors around the world by mail. Officials have also established a return program for all affected products, which had been distributed across the United States and global markets.
Anyone who may be in possession of the MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes is urged to discontinue use of the device and to arrange for a return of the item, which can be identified by the following details:
- Product Name: MEGADYNE™ MEGA SOFT™Pediatric Patient Return Electrode
- Product Code: 0840
- UDI-DI: 10614559103395
As indicated in the FDA communication, further questions about the discontinuation and recall may be directed to the Ethicon Resource Department by calling 1-877-ETHICON (1-877-384-4266). Representatives are available Monday through Friday, from 8:00 a.m. to 5:00 p.m. Eastern Time.
The FDA encourages anyone who experiences adverse reactions or quality issues while using the product to report to the agency’s MedWatch Adverse Event Reporting program.
If your child has suffered a burn injury or another adverse health outcome through the use of a compromised medical device, we would like to learn about your case and help your family pursue fair compensation. Our compassionate attorneys at TruLaw work tirelessly to defend the rights of families like yours and hold negligent parties accountable. To learn about how we can support you in the next steps, contact us online or take our free Instant Case Evaluation ℠.