207. Deputy Pádraig Rice asked the Minister for Health the number of vigilance reports or device-related incident notifications which have been submitted by Children’s Health Ireland (CHI) or the HSE to the Health Products Regulatory Authority in relation to MAGEC rods since the implementation of EU Medical Devices Regulation (MDR) 2017/745; if she will publish a breakdown of the nature of adverse events or faults reported, including mechanical failure, metallosis, or off-label use; and if she will make a statement on the matter. [24709/25]

Summary

207. Deputy Pádraig Rice asked the Minister for Health the number of vigilance reports or device-related incident notifications which have been submitted by Children’s Health Ireland (CHI) or the HSE to the Health Products Regulatory Authority in relation to MAGEC rods since the implementation of EU Medical Devices Regulation (MDR) 2017/745; if she will publish a breakdown of the nature of adverse events or faults reported, including mechanical failure, metallosis, or off-label use; and if she will make a statement on the matter. [24709/25]

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• Medical Aids and Appliances

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