Report Adverse Event

Complaint Details


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.


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.

Click or drag files to this area to upload. You can upload up to 5 files.
Encrypted secure file upload