by the manufacturer and any undesirable side-effect. An incident is considered to be serious when it 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.
In non-UE market, refer to incidents' definitions according to applicable laws.
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