‘Serious adverse event’ means any adverse event that led to any of the following:
(a) a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual's offspring,
(b) death,
(c) serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following:
- (i) life-threatening illness or injury,
- (ii) permanent impairment of a body structure or a body function,
- (iii) hospitalisation or prolongation of patient hospitalisation,
- (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
- (v) chronic disease,
(d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect.
[Definition according to (EU) 2017/746 Article 2 No. 61]