In this form, enter the information that will appear in the Medical device vigilance form to be sent to the ANSM (National Agency for the Safety of Medicines and Health Products).

 

General description

• Medical device vigilance: Code of the ascendant medical device vigilance, unique in the application.
• Title: Name of the medical device vigilance.
• Issuer: Agent responsible for the report.
• Organization: Organization concerned.
• Creation date: For information purposes only, entry date of medical device vigilance.
• Transmittal date: To be filled in on the day when the medical device vigilance is ready, so that it can be closed and sent.
• Status:
  • On Going: Upon creation,
  • Closed: Sent to the ANSM,
  • Canceled: Permanent cancellation.

 

Medical device involved

• Main point: Point with which the defective asset is associated.
• Asset: Code of the defective asset.
• Template: Template of the defective asset.

 

Incident or risk of incident

• Occurrence date: Date of the incident.
• Situation: See the coding on page 2 of the official form.
• Location point: Location of the incident.
• Supplier notification date: To be filled in if the supplier was informed of the incident.
• Circumstances, Consequences, Readings: Free texts that will be entered on the form in similarly named sections.