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Megadyne mega soft patient return electrode
Official notice
14 Jul 2023
Last checked
14 Jul 2023
An official Health Canada notice concerns Megadyne mega soft patient return electrode. 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 Published 2023-07-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73835
Official notice
2023-07-14
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Megadyne Medical, Megadyne Mega Soft Patient Return Electrode.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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