Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
Recall
- Recall Number
- Z-0597-2024
- Event Number
- 93597
- Firm
- Megadyne Medical Products, Inc.
- FEI Number
- 1721194
- Product Code
- GEI
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- December 8, 2023
- Posted
- December 26, 2023
- Address
- 4545 Creek Rd, Blue Ash, OH, 45242-2803
Description
Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
On December 8, 2023, the firm notified customers via URGENT MEDICAL DEVICE CORRECTION letters. The updated IFU will be made available electronically at www.e-ifu.com. Customers were instructed to share the notification update with all users of Mega Soft Universal and Universal Plus pads, and to take steps to ensure that all personnel using the affected product understand and are reminded that the product is not to be used on patients under 12 years old. If you have additional questions regarding this communication or to report any product complaints, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET. UPDATE: Starting in September 2024, the firm communicated to new and existing consignees reiterating the use of affected devices in patients aged 12 years and older. Additionally, the firm's letter informs consignees that the eIFU of devices indicates that no additional materials should be placed between the patient and Mega Soft pad (example: no sheet). On 3/17/25, customers were customers were notified via MEGADYNE MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrode: Voluntary Replacement Program letters. The purpose of this letter is to communicate the availability of a labeling (pad printing) update for MEGADYNE" MEGA SOFT" Universal and Universal Plus Reusable Patient Return Electrodes and availability of these pads for replacement of your current inventory. The pad printing will now show the updated indication which is for patients age 12 years and older. The previous pad printing indicates use for patients greater than 0.8 lbs (0.35 kg). Actions Required 1. Reminder users to only use Mega Soft Patient Return Electrodes on patients 12 years and older, even though these existing devices have labeling of >0.35 kg (>0.8 lb) on the pads. Do not use them on neonates, infants, and children under the age of 12 years old. 2. Compl
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