Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, MEGADYNE, has issued a medical device safety alert concerning MEGADYNE MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes [Product code: 0845, 0846, 0847, 0848] [HKMD No.: 190236].
The manufacturer has received reports of patient burns identified after surgical procedures in which Mega Soft pads were used. The manufacturer has conducted a thorough investigation, and to this point have not identified any design or manufacturing defects, nor have determined definitive root cause. However, the manufacturer has determined that in some instances the Mega Soft pad Instructions for Use (IFU) were not being properly followed.
The Mega Soft pad IFU includes proper setup steps, including that the Mega Soft pad must be thoroughly rinsed after cleaning to ensure residue from cleaning solutions are removed prior to pad use. Failures to follow the Mega Soft pad IFU may contribute to patient burns if cleaning solution residue is not properly rinsed off.
The manufacturer is taking this corrective action to mitigate the potential risk to health in the population of children under 12 years of age.and initiating updates to the IFU and product labelling to reflect that these product codes should not be used in patients under 12 years old. Users should continue to follow the current Mega Soft Instructions for Use (IFU) except for this new limitation in population of intended use.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 Jun 2023
Updated on 18 Dec 2023