MEGADYNE™ MEGA SOFT™
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Catalog excerpts

MEGADYNE™ MEGA SOFT™ - 1

MEGADYNE F'.IP- DF THE ETHICDN- FAMILY OF DQMPAMEl December 8, 2023 URGENT: MEDICAL DEVICE CORRECTION MEGADYNE™ MEGA SOFT™ Universal and Universal Plus Reusable Patient Return Electrodes Important information regarding potential for patient burns and instructions that the following product codes should not be used for patients that are neonatal, infant, and children under the age of 12 years old Dear Operating Room Supervisors, Recall Coordinator, and Director of Materials Management: PLEASE DISTRIBUTE THIS INFORMATION WITHIN YOUR FACILITY TO ALL STAFF INVOLVED in set up, cleaning and use of the MEGADYNE™ MEGA SOFT Reusable Patient Return Electrode. Purpose of this Letter The purpose of this letter is to communicate an important change to the intended use population of the MEGADYNE™ MEGA SOFT™ Universal and Universal Plus Reusable Patient Return Electrodes to help ensure safe and effective use. Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes, listed in the table above, are now limited to use in patients age 12 years or older. Mega Soft Universal and Universal Plus product codes should not be used for patients that are neonatal, infant, and children under the age of 12 years old. This is inclusive of product codes 0845, 0846, 0847, and 0848. The indications and instructions for use for product codes 0800, 0830, 0835 (indicated for patients 25 lbs. and over) and 0840 (indicated for patients from 0.8 lbs. and up to 50 lbs.) remain unchanged. This letter is a notification and is not a product removal. Reason for the Voluntary Correction Megadyne Medical Products, Inc. (“Megadyne”) has received reports of patient burns identified after surgical procedures in which Mega Soft pads were used. Megadyne is taking this corrective action to mitigate the potential risk to health in the population of children under 12 years of age. We have conducted a thorough investigation, and have not identified any design or manufacturing defects, nor have we determined the definitive root cause for the reports. We are initiating updates to the Instructions for Use (IFU) and product labeling to reflect that these product codes should not be used in patients under 12 years old. The IFU update will be made available electronically at www.e-ifu.com. Users should continue to follow the current Mega Soft Medical Device Correction of MEGADYNE™ MEGA SOFT™ Patient Return Ele

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MEGADYNE™ MEGA SOFT™ - 2

Instructions for Use (IFU) except for this new limitation in population of intended use. We will notify customers if we identify any additional actions that may help to ensure safe use of the products. Risk to Health 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. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years. Health care practitioners who have...

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MEGADYNE™ MEGA SOFT™ - 3

PART OF THE ET-ICON- FAMILY OF DOYFAh El As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax: • Online: www.fda.gov/medwatch/report.htm • Regular Mail: Use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 • Fax: 1-800-FDA-0178 Attachments Attachment A: Business Reply Form for Update to Intended Use Population Medical Device Correction of...

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MEGADYNE™ MEGA SOFT™ - 4

PART OF THE ET-ICON- FAMILY OF DOYFAh El December 8, 2023 Attachment A: Business Reply Form for Update to Intended Use Population Business Reply Form (BRF) Your timely response to this notification is requested. Please complete and fax this form to Sedgwick at 888-214-7430 or e-mail the form to Ethicon5627@sedgwick.com within 3 business days. [Account Name] [Account Address] Are you replying for addresses beyond the address listed above? □ Yes □ No If yes, please add additional addresses and J&J Account Number(s) here: Account Name, Address, and J&J Account Number: Medical Device Correction...

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