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.

Step 1: Description of problem

Industry representatives can make complaints about a competitor's medical device(s) through the submission of a trade complaint or report any problem outside the scope of mandatory reporting requirements.

Trade complaint
If this is a complaint about a business or if you would like to report a trade issue, please fill out the next three fields, otherwise skip to the describe your problem field.

Full business name

Website

Full mailing address^{Footnote 5}

Please describe your problem^{Footnote 1} (required)

Date device was purchased (approx.) (YYYY-MM-DD)

How long have you had/used the device? Please select the unit and duration below.

Indicate the numeric value only (i.e. 4, 20, 1.5)

Select the duration (i.e. Days, Minutes, Weeks)

Date the event occured (approx.) (YYYY-MM-DD)

Device user (if other than the reporter) e.g., health care professional^{Footnote 2}

How was the device obtained or purchased (Please include the name, and address or website of the retailer if applicable)

Have you reported this problem to the manufacturer^{Footnote 3} or supplier?

If yes, provide date problem reported (if known) (YYYY-MM-DD)

Manufacturer's name and contact information (if known)

Supplier's name (importer/distributor) and contact information (if known)

If you have any supporting documentation, labels or pictures^{Footnote 4}, please attach and check the box below

Please provide details of the attachments, such as the file name and the document type. Please note that only these file types are accepted: .pdf, .jpg, .doc, .gif

File Name: (maximum file size of 2MB)

Do you have any supporting documentation, labels or pictures^{Footnote 4}, please choose from the dropdown below so Health Canada can contact you to submit via other means (eg.mail)

Step 2: Device details

Device name^{Footnote 6} (required)

Device licence number^{Footnote 7}

Model/Catalogue number^{Footnote 8}

UPC/Bar code^{Footnote 9}

Lot/Batch number^{Footnote 10}

Expiry date^{Footnote 11} (YYYY-MM-DD)
If the day of the month is unknown, please select the last day of that month.

Serial number^{Footnote 12}

Report additional devices

Device 2

Device name^{Footnote 6}

Device licence number^{Footnote 7}

Model/Catalogue number^{Footnote 8}

UPC/Bar code^{Footnote 9}

Lot/Batch number^{Footnote 10}

Expiry date^{Footnote 11} (YYYY-MM-DD)
If the day of the month is unknown, please select the last day of that month.

Serial number^{Footnote 12}

Device 3

Device name^{Footnote 6}

Device licence number^{Footnote 7}

Model/Catalogue number^{Footnote 8}

UPC/Bar code^{Footnote 9}

Lot/Batch number^{Footnote 10}

Expiry date^{Footnote 11} (YYYY-MM-DD)
If the day of the month is unknown, please select the last day of that month.

Serial number^{Footnote 12}

Device 4

Device name^{Footnote 6}

Device licence number^{Footnote 7}

Model/Catalogue number^{Footnote 8}

UPC/Bar code^{Footnote 9}

Lot/Batch number^{Footnote 10}

Expiry date^{Footnote 11} (YYYY-MM-DD)
If the day of the month is unknown, please select the last day of that month.

Serial number^{Footnote 12}

Device 5

Device name^{Footnote 6}

Device licence number^{Footnote 7}

Model/Catalogue number^{Footnote 8}

UPC/Bar code^{Footnote 9}

Lot/Batch number^{Footnote 10}

Expiry date^{Footnote 11} (YYYY-MM-DD)
If the day of the month is unknown, please select the last day of that month.

Serial number^{Footnote 12}

Step 3: Reporter details

First name

Last name

Telephone

Email (required)

Address

City

Province

Country

Postal code

Step 4: Consent

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 share all information, excluding personal information, to the manufacturer/importer/distributer/supplier in order to facilitate verification of compliance, if necessary. (required)

I authorize Health Canada to provide my contact information to the manufacturer/importer/distributer/supplier, in order to facilitate verification of compliance, if necessary. (required)

Step 5: Submit your problem

Once you submit a problem, Health Canada's Regulatory Operations and Enforcement Branch will review the information and take appropriate actions as required and as necessary, which may include following up with you directly.

Footnotes

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.

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Footnote 2

Indicate if a doctor, nurse or other health care professional used the device on you.

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Footnote 3

A manufacturer refers to the company that made the device and whose name and address should appear on the label.

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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.

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Footnote 5

Please include street, city, province/state, country and postal/zip code, if known.

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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

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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.

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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.

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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.

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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".

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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.

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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.

Return to footnote 12 referrer

Page details

Date modified:: 2023-10-05

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Industry Medical Device Report Form

Step 1: Description of problem

Step 2: Device details

Report additional devices

Step 3: Reporter details

Step 4: Consent

Step 5: Submit your problem

Footnotes

Page details