The FDA is advising healthcare providers that Megadyne has recalled its MEGADYNE MEGA SOFT Pediatric Patient Return Electrode because use of the device has been found to cause burns. The recall has been identified as the most serious type (Class I) because product use may lead to a major injury or death.
Designed to be used by children weighing between 0.8 and 50 pounds, MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes are soft pads implemented during electrosurgery. The procedure stops bleeding using an electric current, which is produced by an electrosurgical generator and then is conveyed with “a small pen-like attachment” which heats or cuts tissue. To mitigate the risk of over-heating, a return electrode pad makes contact with a patient’s skin as they are lying down, conducting the electric current from the patient’s tissue back to the generator.
Megadyne announced the action on June 13, 2024, after receiving reports that linked patient burn injuries with procedures in which MEGADYNE MEGA SOFT Patient Return Electrodes were used. Officials have determined that using an affected device could put pediatric patients at risk for major adverse health outcomes, including “third-degree burns, scarring,” and other conditions that may require additional surgeries.
To date, the company has been notified of four injuries and no deaths in connection to the problem. Following the reports, Megadyne has alerted affected healthcare providers and facilities to cease all use of the devices and arrange for their return to the company.
An Urgent Medical Device Recall (Removal) letter sent to customers on May 8, 2024 made the following recommendations:
- Assess facility inventory and identify any product subject to the recall: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode under product code 0840 and Unique Device Indentifier (UDI):10614559103395.
- Ensure all affected devices are quarantined, and that a copy of the notice is placed next to the products.
- Ensure all relevant personnel (“operating room or materials management staff,” other facility members) is notified of the issue.
- In the event that the recalled product has been sub-distributed to another facility, ensure that the facility is notified with arrangements to return the product. A copy of the recall letter should also be forwarded with the the communication.
- The Business Reply Form (BRF) enclosed in the letter should be completed and returned to confirm receipt of the notification. Customers should fax Sedgwick at 800-978-9457 or email the form to ethicon4284@sedgwick.com in no later than three business days. Even if a customer is not in possession of a recalled product, the BRF should be returned.
- Customers should be aware that all recalled MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes are required to be returned.
- All recalled products must be returned no later than August 31, 2024 in order to receive a credit reimbursement. No credit will be reimbursed for non-affected products or products returned past the date.
- To arrange a return, ensure a copy of the BRF is included with the product in the box. Customers should then affix the pre-paid authorized shipping label included with the notification letter.
- Contact Sedgwick at 888-912-7090 and reference Event #4284 for help with the return or to obtain more shipping labels.
- Until all recalled product has been returned to Sedgwick, ensure the notice is posted and made visible to all relevant personnel.
U.S. customers may direct recall-related questions to Ethicon Resource Department at 1-877-ETHICON, or 1-877-384-4266.
Has your child suffered a burn injury or an adverse health outcome after using a recalled electrode pad? Your case warrants attention and your family deserves fair compensation. Our compassionate attorneys at TruLaw are personally motivated in protecting consumer safety standards and holding negligent parties accountable. To learn more about how we can support you in the next steps, contact us online or try out our free Instant Case Evaluation ℠.