Megadyne Mega Soft Patient Return Electrode
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Mega Soft Universal Patient Return Electrode |
All lots that are within shelf-life |
0846 |
Mega Soft Dual Universal Plus Patient Return Electrode |
All lots that are within shelf-life |
0848 |
Mega2000 Patient Return Electrode |
All lots that are within shelf-life |
0800 |
Mega2000 Soft Patient Pad Return Electrode |
All lots that are within shelf-life |
0835 |
Mega Soft Universal Plus Patient Return Electrode |
All lots that are within shelf-life |
0847 |
Issue
Megadyne Medical Products, Inc. (“Megadyne”) has received reports of patient burns identified after surgical procedures in which Mega Soft pads were used. Megadyne is aware of 63 complaints of serious patient burns globally since April 2018. Megadyne has conducted a thorough investigation, and to this point have not identified any design or manufacturing defects, nor determined definitive root cause. However, Megadyne has determined that in some instances the Mega Soft pad Instructions for Use (IFU) were not being properly followed.
Recall start date: June 6, 2023
Additional information
Details
Megadyne Medical Products Inc.
4545 Creek Road, Cincinnati, Ohio, United States, 45242
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