Serious Adverse Drug Reactions | Medical Device Incidents

Patient Safety Coordinators Contact Information:
Tara Roberts or 204-903-5344
Pam Gunn or 204-903-7762

See Admin Updates for recent monthly updates

Any serious documented Adverse Drug Reaction (whether it is suspected or confirmed) and any Medical Device Incidents need to be reported to Health Canada within 30 calendar days of first documentation of event. A regional process for submissions of these reports has been created to streamline the reporting process for tracking purposes. All reports are to be scanned directly to . Mandatory reporting came into effect on December 16, 2019 under the new federal legislation “Vanessa’s Law”. The law only applies to Acute Care Hospitals including Acute Care Affiliate Health Corporations. (Voluntary reporting is encouraged in all health care settings.)

How to Report SADRs and MDIs

Management of Serious Adverse Drug Reactions and Medical Device Incidents Checklist
Management of an Adverse Event Following Immunization Checklist
Health Canada Serious Adverse Drug Reaction Reporting Form for Hospitals
Medical Device Problem Reporting Form for Health Care Professionals

Fiscal SADRs and MDIs Reports

April 1, 2023 to March 31, 2024
Annual Report

April 1, 2022 to March 31, 2023
Annual Report