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Drugs and Health Products

Health Product Complaint Form (FRM-0317)

There are 2 different forms for submitting a complaint depending on the type of health product involved:

  • Type of Health Products
    • Blood and blood components
    • Cells, tissues, organs
    • Clinical trial study for health products
    • Donor semen
    • Drugs (Animal use)
    • Drugs (Human use including biologics)
    • Medical devices
    • Natural health products
    • Xenografts
  • Complaint (examples)
    • Health Product quality (such as a medication having a foul odor)
    • Labelling errors
    • Health Product mix-ups, incorrect components, particulate matter, foreign materials, contamination etc.
    • Unapproved / unauthorised sale and/or advertising (e.g. no product licence, unapproved health claims etc.)
    • Sale of unlicensed products on the internet
    • Tampering/Sabotage
    • Concerns about the safety of a device or its ability to perform as claimed
    • Violation of the Food and Drugs Act and associated Regulations by a Competitor
    • Clinical trials complaints
    • Counterfeit products
  1. For all health product complaints (except medical devices) access online form.

    If you are reporting an error and / or accident involving human cells, tissues and organs for transplantation, please use Human Cells, Tissues and Organs for Transplantation - Error or Accident Investigation Preliminary Report Form (FRM-0172).

    If you are reporting an error and / or accident involving blood collected for transfusion or for use in the manufacture of a drug for human use, please use FRM-0337

  2. For medical devices complaints only complete the form below.

    If you represent a company whose device is linked to an incident and qualifies as a Mandatory Problem Report, please use Mandatory Medical Device Problem Reporting Form for Industry

    Provision of the information requested on this form is voluntary.

    Personal information is collected under the authority of the Next link will take you to another Web site Food and Drugs Act and the Next link will take you to another Web site Privacy Act for the purpose of delivering national compliance and enforcement activities of health products under the Inspectorate's mandate. Failure to provide personal information may affect Health Canada's ability to effectively meet this purpose.

    Your personal information when disclosed to the Inspectorate is confidential and protected. This information is administered and retained in accordance with the Food and Drugs Act and is protected as personal information under the Privacy Act, and in the case of an access to information request, under the Next link will take you to another Web site Access to Information Act. Your personal information is stored and maintained in an appropriate database and / or filed in accordance with the department's best practices.

    You have the right to access your personal information and request changes if the information is incorrect. Details on personal information collected under this program are outlined on the Next link will take you to another Web site Info Sources Web site and are described in the Health Canada section (see Personal Information Bank(s) - HC PPU 405, 406, 407, and 408).

    Questions or comments regarding the administration of the Privacy Act in our Department may be directed to the Health Canada's Access to Information and Privacy Coordinator. For additional information on privacy issues and the Privacy Act in general, consult the Next link will take you to another Web site Office of the Privacy Commissioner of Canada or call 1 (800) 282-1376 or (613) 947-1698.

Online Form - (Medical Devices Only) - FRM-0317

Protected A (when completed)

Type of Health Product: Medical Devices

[1] Information About Who is Reporting

Reporter (consumer, user, healthcare professional, clinic manager, etc.) If you are reporting a complaint about a medical device, please complete the section entitled "Reporter". Provide the requested information, such as, your name, telephone number, and complete address.
NOTE: Failure to provide accurate personal information may limit the Inspectorate's ability to effectively follow-up on the incident.

If you are an industry representative complaining about competitor's medical device(s), complete the sections entitled "Reporter" and "Trade Complaints (Industry)".
NOTE: Failure to provide accurate personal information may limit the Inspectorate's ability to effectively follow-up on the incident.

Medical Device Information (as it appears on the Label/Package/Device)

Provide detailed information about the Medical Device you are reporting.

For example:

  • Device Name
  • Device Licence Number
  • Model/Catalogue Number
  • Serial Number (if available)
  • UPC/Bar Code (if available)
  • Lot/Batch Number
  • Expiry Date
  • Manufacturer's name and contact information (as appears on the label; no abbreviations)
  • Supplier's name (Importer/Distributor) and contact information (as appears on the label; no abbreviations)
  • Contact details of the place from where the product was acquired, date acquired (approx.), how long the product was used for, approximate date the incident occurred
  • If the reporter is other than the product user, provide details of the user

Confirm if:

  • The device / label is available for evaluation for Health Canada
  • The incident has been reported to the manufacturer and/or retail store. If yes, provide the date the incident was reported and any contact information of the individual to whom the incident was reported.

Is the device / label available for evaluation?

Have you reported this complaint to the manufacturer or retail store?

  • what, when, where, who, and how the incident happened; any injuries / death; other relevant medical information
  • copies of the device label in question
  • advertising and/or promotional materials, including websites
  • price lists or order forms or flyers which show the name of the company and device in question
  • any other information which would assist the Inspectorate in verifying the incident
Attach any photos, images, documents with the incident form and provide details of the attachments, such as file name and document type. Please note that ONLY these file types are accepted: .pdf, .jpg, .doc, .gif, .zip
 

Please provide your consent by selecting Yes or No in the Authorization field. Providing consent better facilitates verification of compliance.

I authorize Health Canada to provide my contact information to the manufacturer / importer / distributer or supplier, in order to facilitate verification of compliance, if necessary.*
I authorize Health Canada to release the contents of this report and refer my incident and product details to another organization outside Health Canada to facilitate verification of compliance, if necessary.*
If applicable, I authorize Health Canada to release the sample / specimen provided, to the manufacturer / importer for evaluation.* NOTE: Submission of sample(s) to Health Canada relinquishes your ownership rights to that sample.

Select your province/territory to find the Inspectorate program office responsible for your province/territory.

Table: Locations outside of Canada
Your location outside of Canada Select Province / Territory

United States: Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, Rhode Island, Vermont

Middle East: Bahrain, Cyprus, Iran, Israel, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, Syria, Turkey, United Arab Emirates, West Bank and Gaza Strip, Yemen

Atlantic

United States: District of Columbia, Florida, Georgia, New York, North Carolina, Pennsylvania, South Carolina, Virginia, West Virginia

All islands in the Caribbean

Central America: Belize, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama

Scandinavia &Baltic States: Denmark, Estonia, Finland, Latvia, Lithuania, Norway, Sweden

Central Europe: Austria, Belgium, France, Germany, Liechtenstein, Luxembourg, Netherlands, Switzerland

Quebec

United States: Alabama, Illinois, Indiana, Kentucky, Michigan, Mississippi, Ohio, Tennessee, Wisconsin

Northern Europe: Iceland, Ireland, United Kingdom (England, Scotland, Wales, Northern Ireland)

Eastern Europe: Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Serbia, Slovak Republic, Slovenia

Southern Europe: Greece, Holy See, Italy, Malta, Monaco, Portugal, San Marino, Spain

All countries in South America

Ontario

United States : Arkansas, Iowa, Kansas, Louisiana, Minnesota, Missouri, Nebraska, North Dakota, Oklahoma, South Dakota, Texas

All countries in Africa

Mexico

Manitoba and Saskatchewan

United States: Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming

Australia

New Zealand

All islands in the South Pacific

Alberta

United States: Alaska, California, Hawaii, Oregon, Washington

All countries in Asia

British Columbia