Report Adverse Event

Complaint Details

Definitions

Mild: Easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. These events generally do not require treatment.

Moderate: Sufficiently discomforting to interfere with normal everyday activities. These vents are usually relieved by simple therapeutic measures.

Severe: Prevents normal, everyday activities. These events may require systemic drug therapy or other medical treatment.

Definitions

Not Related: An event for which an alternative explanation is conclusively identified–e.g., concomitant drug(s), concomitant disease(s), and/or the relationship in time suggests that a causal relationship is highly unlikely.

Related: The adverse event follows a reasonable temporal sequence related to treatment by the device, follows a known or suspected response pattern and a plausible alternative etiology cannot be identified.

Undetermined: The relation of the adverse event has some temporal relationship to the device and/or device procedure, is not clearly due to another condition and the involvement of the study device is unknown.

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