Harm. Physical injury or damage to the health of people, or damage to property or the environment. Immediately, without any delay that could not be justified. Incident: • Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to serious injury or the death of a patient, or user or of other persons or to a serious deterioration in their state of health. • Any technical or medical reason related to the characteristics or performances of a device (see first bullet point) that leads to a systematic recall of devices of the same type by the manufacturer.
Appears in 2 contracts
Sources: Exclusive License, Supply and Distribution Agreement (Bioventus Inc.), Exclusive License, Supply and Distribution Agreement (Bioventus Inc.)