In Canada, when a problem occurs with a medical device or a patient using one — anything from a battery failing unexpectedly to a death — the event can be reported to Health Canada by companies, doctors, hospitals or patients. These “medical device incidents” are categorized by severity, with the worst being injury and death.
In the United States, medical device reports are publicly available, but not in Canada.
Using access-to-information requests, CBC News obtained a copy of Health Canada's database and created a publicly searchable portal of incidents since 1977.
You can search it by typing a product’s brand name or manufacturer, a health problem, or a device type (e.g. hip implant, pacemaker, insulin pump). You’ll get information on the deaths, injuries and recalls reported to Health Canada while the medical devices were licensed for use in Canada.
Do you have a story about a medical device? CBC News wants to hear from you: medicaldevices@cbc.ca.
The CBC makes this information available under terms and conditions outlined below.
Explore the medical device incidents database
Data available for devices licensed for use in Canada between 1977 and 2018
Read the response from the industry group representing device manufacturers (MEDEC)
This database includes data from Jan.1, 1977, to Oct. 19, 2018, only. CBC will not update the database.
The information in this data set represents what Health Canada calls “spontaneous” incidents. Health Canada collects and uses this data to detect possible signals of adverse reactions associated with health products. If a device is included in this database, it does not mean the listed problem, injury or death was necessarily caused by the device.
This data is collected primarily on a voluntary basis, and Health Canada cautions on its website that adverse reactions are often underreported to both mandatory and voluntary surveillance systems. This makes the data an incomplete snapshot of the actual number of medical device incidents that occur in Canada.
CBC has not verified the accuracy of the data. Reports might have been filed to Health Canada with inaccurate or incomplete information. There is no certainty that the medical device caused the reported reaction. A given reaction may be the result of an underlying disease, process or another coincidental factor. One report may be tied to multiple parts of the same device and multiple reactions may be connected to a single patient. The data does not reflect any CBC assessment of association between the health product and the reaction(s).
This database is not meant to be used for medical diagnosis. If you find your device in the database, consult a physician before drawing conclusions.
The number of adverse reports should not be used as a basis for determining the incidence of a reaction or for estimating risk of a particular medical device, as neither the total number of reactions occurring nor the number of patients exposed to the device is known. Because of the multiple factors that influence reporting, quantitative comparisons of medical device safety cannot be made from the data.
In order to be entered into the database, information from an adverse reaction report is coded using keywords (reaction terms), which represent the reaction(s) described in the case report.
Health Canada warns that, in some cases, duplicate reports can exist if the same incident is reported by different sources (for example: a company, hospital, doctor or patient). This may mean that the total number of incident reports may not reflect the number of incidents.