Faulty or harmful medical device: report the incident to Health Canada
Get necessary care, preserve the device information and complete Health Canada’s consumer reporting form.
If the device causes immediate danger, serious injury or a critical treatment interruption, call emergency services or the care team. The reporting form is not medical care.
Stabilize the situation
Stop using the device if a clinician or the safety instructions recommend it. For an implant or life-sustaining device, do not alter anything without clinical advice unless there is an immediate emergency.
Preserve the information
Photograph the product, packaging and error messages. Record the manufacturer, model, serial or lot number, purchase date and place, circumstances, medical effects and supplier information. Do not erase useful logs or settings.
Make separate reports
Notify the clinician, hospital, pharmacy or supplier so that care and traceability can be managed. A consumer may also voluntarily submit a report directly to Health Canada using the dedicated form.
After submission
Keep the file number, receipts, medical reports and correspondence. A regulatory report does not automatically provide a refund or compensation; those remedies must be pursued separately with the seller, manufacturer, insurer or an adviser.
Consumer medical device report — Health Canada