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Report a medical device problem (for health care professionals)

Privacy Statement

Privacy notice: The personal information you provide to Health Canada is governed in accordance with the Privacy Act. We only collect the information we need to administer the Medical device problem reporting program authorized by the Department of Health Act, Section 4(h), and the Food and Drugs Act, Section23 (1) (c) and the Medical Devices Regulations, Section(s) 59 (1) (a) (b) (2), 60, 61.1 (1), 62, 63, 64, 65, 77, 81(k) (v) (2) and 88 (c).

Purpose of collection: We require your information to assess the nature of the report and to fulfill the Health Products and Food Branch (HPFB) program’s responsibilities for monitoring the use of medical devices in Canada. Personal information regarding the Submitter, collected from the medical device problem reports, may be used to conduct follow-up of a medical device incident; to monitor the safety and efficacy of marketed medical devices; for compliance and enforcement activities; to request safety and efficacy information from the manufacturers, health care professionals / practitioners / facilities and other users of marketed medical devices for the purpose of post-market surveillance of medical devices, to report to senior management, or to complete a trend analysis. Trend and safety data in a de-identified format may be communicated by a variety of risk communication tools (including a monthly Health Canada newsletter – Infowatch – and an incident database/data extracts) and / or responses to inquiries.

Other uses or disclosures: Your personal information may also be provided to the Manufacturer/Importer of the device in the event that they require follow-up of a medical device incident. In limited and specific situations, your personal information may be disclosed without your consent in accordance with subsection 8 (2) of the Privacy Act.

Refusal to provide the information: If the report governed under the above sections was not provided when known, in the unlikely event that a situation of non-compliance is not resolved through this cooperative, staged approach, Health Canada could potentially use provisions of the Food and Drugs Act and its associated regulations, for example, to seek an injunction under section 21.5 of the Act, to compel a reporter to comply with the regulations.

For more information: This personal information collected is described in Info Source, available online at https://www.canada.ca/en/health-canada/corporate/about-health-canada/activities-responsibilities/access-information-privacy/info-source-federal-government-employee-information.html#a26. Refer to the personal information bank, HC PPU 415.

Your rights under the Privacy Act: In addition to protecting your personal information, the Privacy Act gives you the right to request access to and correction of your personal information. For more information about these rights, or about our privacy practices, please contact the Privacy Coordinator at 613-946-3179 or hc.privacy-vie.privee.sc@canada.ca. You also have the right to file a complaint with the Privacy Commissioner of Canada if you think your personal information has been handled improperly.

About

Reporting by hospitals is required

Section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to Health Canada all serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of being documented within the hospital.

Who is regulated

This regulatory requirement only applies to hospitals.

Hospital is defined as a facility that:
  • is licensed, approved or designated as a hospital by a province or territory, in accordance with the laws of the province or territory, to provide care or treatment to persons suffering from any form of disease or illness; or
  • is operated by the Government of Canada and provides health services to in-patients.

What to report

A serious ADR is a noxious and unintended response to a drug that occurs at any dose and that:
  • requires in-patient hospitalization or prolongs existing hospitalization
  • causes congenital malformation
  • results in persistent or significant disability or incapacity, or
  • is life-threatening or results in death.

A MDI means an incident related to a failure of a medical device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use that has led to the death or a serious deterioration in the state of health of a patient, user, or other person, or could do so were it to recur.

What therapeutic products are within scope

The mandatory reporting requirements for hospitals apply to the following therapeutic products:
  • pharmaceuticals (prescription and non-prescription);
  • biologic drugs (biotechnology products, DIN-assigned manufactured blood products, as well as vaccines, excluding those administered under a routine immunization program of a province or territory);
  • radiopharmaceutical drugs;
  • disinfectants;
  • drugs for an urgent public health need;
  • medical devices.

Additional information on the regulatory requirements related to mandatory reporting can be found in the guidance document intended for hospitals.

When in doubt, Health Canada encourages hospitals to report.

Contact

For additional information on the Canada Vigilance Program or about mandatory reporting of serious ADRs/MDIs:
Instructions

A. Report and submitter information

: Indicate whether the report is the first one submitted for this specific medical device incident (i.e. initial) or a follow-up to a previously submitted report

Health Canada reference number: If the report is identified as a follow-up, provide reference number generated by Health Canada and provided to the submitter further to the initial report submission

Internal submitter file number: Indicate the hospital’s identification number for the case. For follow-up reports, the report number should be the same as the number assigned to the initial report

: Select the highest impact of the incident in the report: Death, serious deterioration of health (this term means a life-threatening disease, disorder or abnormal physical state, the permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage), potential for serious harm (i.e. death or serious deterioration in health; known as near incidents), or other (provide more details in incident narrative)

: For hospitals, indicate the date when the medical device incident was first documented. For all others, indicate the date of awareness

: Enter the submitter’s names

: Enter the telephone number and/or email address to contact in the case of follow-up

Fax : Enter a facsimile number to contact in the case of follow-up

: Enter the full name of the reporting organization

: Select if the report is being submitted to fulfill obligations for Mandatory reporting for hospitals under sections 62 of the Medical Devices Regulations (MDRs), for Investigational testing under section 88 c) of the MDRs, for Special access program under section 77 of the MDRs, or for voluntary participation in the Canadian Medical Devices Sentinel Network (CMDSNet) program

ITA authorization no./SAP reference number: Enter the Investigational Testing Authorization number or Special Access Program reference number, if applicable

Profession: Select the submitter’s profession

Department: Enter the submitter’s department

Health Canada institutional ID: Indicate the submitter’s unique hospital identifier as assigned by Health Canada. To obtain this identifier, please contact hc.canadavigilance.sc@canada.ca. Address details do not need to be completed if this unique number is provided

Address/City/Province-Territory/Postal code: Enter the submitter’s facility/hospital/institution/organizational civic address

Alternative contact: Provide an alternative contact

Seriousness of the incident: Select one or more criteria that makes the report a serious medical device incident, if applicable. Enter date of death if known. Partial dates are acceptable

B. Affected person

Person’s ID: Provide a person identifier in order to readily locate the case for follow-up purposes. This can be the person’s initials or the record number. Please do not provide the full name of the person

Who was affected? Select the category of person most affected by the incident. N/A should be used when no one was injured; potential for harm should be selected in Type of event

Vulnerable population? Indicate whether the affected person is part of a vulnerable population. Pediatric is defined as 21 years of age or younger. Geriatric is 65 years of age or older. Select the most relevant vulnerable population. If applicable, indicate other populations in Other field

Height: Enter the person’s height

Weight: Enter the person’s weight

Sex: Enter the affected person’s biological sex. Intersex is a term used for a variety of conditions in which a person is born with a reproductive anatomy that does not fit the typical definitions of female or male

Age: Provide the person’s age at the time of the incident

: Detail the outcome of the incident for the affected person

: Provide any other pertinent details of the affected person which may have had an impact on the incident

Were there other people involved? Select either Yes/No. If so, how many? Indicate number of people involved in the incident

Describe the impact on other people involved: Provide any relevant information related to the fields listed above. If needed, additional text can be added to Section F (Additional details)

C. Device information

: Provide the name of the device as per the product label, or information that can uniquely identify the device from others. You must provide either Device name or Device identifier as essential information

Device model: Enter the model of the device as per the product label, or information that can uniquely identify the device from others

: Enter the device identifier found on the label or information that can uniquely identify the device from others, such as a bar code or GTIN. You must provide either Device name or Device identifier as essential information

: Enter the serial number of the device

Catalogue number: Provide the catalogue number of the device

: Provide the lot, control, or batch number of the device

Software and version: Provide the software and version number

Unique device identifier (UDI): Provide the UDI assigned to medical devices by the manufacturer of the device

Start and end of use dates/duration: Provide the time frame details for device use. Partial dates are acceptable

Expiry date: Provide the expiry date of the device per the label. Partial dates are acceptable

Age of device: Provide the age of the device

: Indicate the name of the medical device manufacturer and if the incident details were also provided to the manufacturer. If so, please also provide the date that it was reported to the manufacturer and the reference number if known. Partial dates are acceptable

Vendor details: Indicate the same information as above, but for a report provided to the vendor of the medical device

Was the device returned to the manufacturer? Indicate if the device was returned to the manufacturer and, if so, provide the date returned. Partial dates are acceptable. If not, indicate if it is available for assessment

Implantation details: Provide implantation details if applicable

Was more than one of this device involved? Select Yes/No if there were multiples of the same device used in this particular incident. I.e. Three out of thirteen pads were used in the procedure (ten were defective, three were suitable for use)

Usage of device: Select the most appropriate device usage. If not applicable or more than one usage, enter the details in the Other section

: Please provide any pertinent device details that may have had an impact on the incident

D. Incident information

Date of incident: Provide the date of the medical device incident. Partial dates are acceptable

Source of report: Select the complainant who contacted the submitter to inform them about the incident

Is this a recurring issue? Select Yes/No to indicate if this type of incident has occurred previously in your organization

If so, how many times? Indicate the amount of times it has occurred

In which country did the incident occur? Indicate if the incident occurred in Canada or not. If Other is selected, please describe the circumstances under the Incident details

Location of the incident: Select from the list the setting of the incident

: Provide a detailed description of the incident including information on what happened in the incident, the outcome of the affected persons involved if known, device(s) and equipment(s) involved, and other concomitant therapy involved during the incident

E. Action taken

This section contains information about any actions taken as a result of the medical device incident. These are not legally required but they provide additional information about the incident for Health Canada’s consideration

Actions taken by hospital: Includes information on any relevant actions taken by the hospital or the healthcare professionals to correct the problem or any preventive actions, if known

Actions taken by manufacturer/vendor: Includes information on any relevant actions taken by the manufacturer/vendor to investigate or correct the problem, if known.

F. Additional details

This section provides space for additional information about affected persons, other devices involved, or details for the narrative if required

For more details, refer to the Guidance Document for hospitals at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-hospital-reporting/drugs-devices.htm


(hospital is exempt from mandatory reporting if this information is unavailable)

(if information is in the control of or reasonably accessible by the hospital for mandatory reporting)

Specific field instructions are included in the Instructions section above.

A. Report and Submitter Information































B. Affected Person












C. Device Information

































D. Incident Information (Continue in Section F if necessary)







E. Actions Taken


F. Additional Details

Before submitting your report, please review the information you provided.

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