Unanticipated Adverse Device Effects
Unanticipated adverse device effects are any serious adverse effect on health or safety or any life-threatening problem or death caused by (or associated with) a device. It only applies if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application). It also includes any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of participants. (NIH)
