Medical masks and respirators: Report a problem or concern

On this page

• Consumers
• Health care providers
• Manufacturers

Consumers

We strongly encourage everyone who witnesses or experiences a problem with a medical device to report it. This includes the sale of unauthorized devices.

You can also work with your health care provider to submit a report. Your provider may have additional information that could be useful for our assessment. Report whatever information you may have, even if you're not sure of all the specific details needed.

Report a medical device problem or concern – consumers

Health care providers

Health care providers who witness, experience or hear about a medical device problem are strongly encouraged to report it.

Report a medical device problem or concern – health care providers

We provide many sources of information on medical device safety and risks, including:

• MedEffect Canada, where we post the results of our safety reviews
• MedEffect e-Notice, where you can subscribe to receive health product safety alerts automatically
• recalls and safety alerts, where:
  • we post medical device recalls
  • you can subscribe to receive information on safety risks about medical devices
• medical device incidents database
  • note the disclaimer for the limitations of the database
• general information on medical devices and our related action plan
• summaries of decisions, where we provide background information that could be relevant in treating your patients

Manufacturers

All manufacturers of medical devices must report all incidents in accordance with sections 59 through 61.1(2) of the Medical Devices Regulations.

Report a medical device incident – industry