Industry Medical Device Report Form
Privacy Notice Statement
Provision of the information requested on this form is voluntary.
Personal information is collected under the authority of the Food and Drugs Act and the Privacy Act for the purpose of delivering national compliance and enforcement activities of health products under the Health Canada mandate. Failure to provide personal information may affect Health Canada's ability to effectively meet this purpose.
Your personal information when disclosed to the Health Canada 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 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 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 Office of the Privacy Commissioner of Canada or call 1 (800) 282-1376 or (613) 947-1698.
- Footnote 1
Include as much detail as possible when describing your problem report. Information on what, when, where, who and how the incident happened; any injuries/death; other relevant medical information. Be sure to include information about the type of device involved with the issue. For example: toothbrush, tampon, hip implant.
- Footnote 2
Indicate if a doctor, nurse or other health care professional used the device on you.
- Footnote 3
A manufacturer refers to the company that made the device and whose name and address should appear on the label.
- Footnote 4
Labels are copies of labels or information about that device found on the device itself or on the device packaging (e.g., barcodes, instructions for use).
Supporting documentation is any document that includes information about the device. It can be a brochure from the doctor's office, instruction pamphlet, implant registration card, etc.
Pictures include a picture of the device itself and/or the defect with the device, if possible. Could also include screenshots from websites.
- Footnote 5
Please include street, city, province/state, country and postal/zip code, if known.
- Footnote 6
The device name is usually found on label and may include a brand or trade name. Be sure to include the entire brand or trade name
- Footnote 7
The device licence number is issued by Health Canada but does not normally appear on the label. Additionally, some medical devices do not require a device licence. If a medical device has a device licence, then the licence number can be found by searching Health Canada's online Medical Devices Active Licence Listing (MDALL), which can be found at: https://health-products.canada.ca/mdall-limh/index-eng.jsp.
- Footnote 8
Usually a model number, catalogue number or Ref. No. found on the device, label, or instruction for use. This information helps Health Canada identify the specific device that requires follow-up.
- Footnote 9
A Universal Product Code (UPC) consists of 12 numbers that are unique to that device and can be found along the bottom edge of the barcode. The barcode is usually found on the label of the device, but may not be available if the packaging or label has been discarded.
- Footnote 10
A lot or batch number is a unique series of letters and/or numbers that identify a particular production run or batch of devices. If a device has a lot number, it normally appears on the label. Sometimes, lot numbers are preceded by the word "Lot".
- Footnote 11
If a device has an expiry date, it will normally include the year and month, and may include the day (e.g., 2021-09-14). The expiry date is normally found on the label and is often preceded by an hourglass symbol.
- Footnote 12
A serial number is a unique series of letters and/or numbers that identify a specific device. If a device has a serial number, it normally appears on the device. The letters "SN" sometimes precede serial numbers.
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