‘Serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person,
(b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
(c) a serious public health threat.
[Definition under (EU) 2017/745 Article 2 No. 65 also corresponds to definition under (EU) 2017/746 Article 2 No. 68]