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.

Related to Adverse Device Effect

  • Adverse determination means a final action or adjudication that the person or entity in question has committed Wage Theft or Payroll Fraud and is further defined in Chapter 190.

  • Adverse decision means a utilization review determination by the utilization review entity that a

  • Adverse system impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Final Adverse Determination means an Adverse Determination involving a Covered Service that has been upheld by Blue Cross and Blue Shield or its designated utilization review organization, at the completion of Blue Cross and Blue Shield's internal grievance process procedures.