This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Adverse Device Effect (ADE)
Adverse Device Effect (ADE)
An adverse event related to the use of a medical device. This definition includes any adverse event resulting from insufficiencies or inadequacies in the instructions for use, the deployment, the implantation, the installation, the operation, or any malfunction of the investigational medical device, and any event resulting from use error or intentional misuse of the investigational medical device.