Adverse Device Effect definition

Adverse Device Effect. (ADE) means an adverse event related to the use of a medical device. This 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 medical device. This also includes any event that is a result of a use error or intentional misuse.
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Examples of Adverse Device Effect in a sentence

  • Should the EDC system become non-operational, the site must complete the appropriate paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency Form.

  • Adverse Device Effect (ADE) AE related to the use of an investigational medical device (test product) or control product.

  • Refer to Section 11 for additional Significant Non-Serious AEs. Unanticipated Serious Adverse Device Effect Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the risk management file.

  • Serious Adverse Device Effect (SADE) ADE that has resulted in any of the consequences characteristic of an SAE.

  • Should the EDC system become nonoperational, the site must complete the appropriate paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency Form.

  • Anticipated Serious Adverse Device Effect (ASADE) Serious ADE which by its nature, incidence, severity or outcome has been identified in the risk management file.

  • Refer to Section 11 for additional Significant Non-Serious AEs. Unanticipated Serious Adverse Device Effect Serious adverse device effect which by its nature, incidence, severity, or outcome has not been identified in the risk management file.

  • MRK shall have sole and full responsibility for taking any actions that MRK, in its sole discretion considers necessary to ensure Subject safety including the timely termination of a Clinical Trial, if an Unanticipated Adverse Device Effect is considered by MRK to present an unreasonable risk to the Subjects.

  • Unanticipated Serious Adverse Device Effect Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the risk management file.

  • Serious Adverse Device Effect (SADE) Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.