Problem Reporting for Medical Devices - User Problem Report Form (FRM-0029)

Contact Information

User Reporter Information

Note: * The contact information in Fields 1 and 2 is essential for follow-up.

1. * Name/Title:

2. * Telephone number: (  )

3. E-mail:

4. User

1. Name of facility:
2. Street address:
3. City:
4. Province:
5. Postal Code:
6. Facsimile number: (  )

Medical Device Details

5. Trade/Brand Name:

6. Type of device:

1. Model #:
2. Catalogue #:
3. Serial #:
4. Lot #:
5. Other # (specify):

7. Manufacturer's name:

1. Street address:
2. City:
3. Province/State:
4. Postal/Zip Code:

8. Distributor's/Supplier's name:

1. Street address:
2. City:
3. Province/State:
4. Postal/Zip Code:

9. Date the device was purchased (yyyy/mm):

10. How long the device was in use prior to the incident? (yyyy/mm):

11. Expiration date, if applicable (yyyy/mm/dd):

12. If implanted, give date (yyyy/mm/dd):

13. If explanted, give date (yyyy/mm/dd):

14. Device available for evaluation by Health Canada?

1. Yes
2. No - Disposed of by hospital/reporter
3. No - Retained by hospital/reporter
4. No - Returned to manufacturer on (yyyy/mm/dd):
5. No - Other explanation

Description of Incident

15. Date the incident occurred (yyyy/mm/dd):

16. Date the incident was reported to the:

1. Manufacturer (yyyy/mm/dd):
2. Distributor/Supplier (yyyy/mm/dd):
3. Not reported. Please provide rationale why it was not reported:

17. User of device (if other than reporter)

1. Health professional, specify:
2. Technician, specify:
3. General public/patient, specify:

18. Patient outcome attributed to incident:

1. Death (yyyy/mm/dd)
2. Injury
3. Potential for death/injury
4. Minimal/no adverse health consequences

19. Please include as much detail as is known about the incident (for example: what happened and to whom, was contamination or lack of sterility involved), or the nature of the defect:

20. Please provide any comments or additional information. This may include relevant tests/laboratory data including dates, relevant patient history, and/or therapy dates and other medical products in use at the time of the incident including dates, time to symptom onset, time of symptom duration, concomitant drugs, and de-challenge response to concomitant drugs.

21. Authorizations

• I authorize Health Canada to provide my contact information to the manufacturer/importer, in order to facilitate the investigation by the manufacturer/importer into my problem report.
• I authorize Health Canada to release the sample/specimen provided to them, to the manufacturer/importer for evaluation.

Additional instructions for completing the final report

For a full explanation of medical device user problem reporting and the reporting of incidents to Health Canada, please see the guidance document entitled, "User Problem Reporting for Medical Devices (GUI-0060)". Additional guidance is provided, here, only for clarification.

Reporter Information

This section of the form includes primary contact information for the person who is reporting the incident to Health Canada. Of primary importance is your name and telephone number.

Medical Device Details

This section allows Health Canada to accurately identify the medical device involved in the incident or complaint. Although all sections should be completed, of primary importance are the trade name of the device (as stated on the label), the model number and the manufacturer's device identifier.

This section also includes the name and address of the manufacturer of the device and of the supplier who sold you the device.

Lastly, this section requests additional information concerning the use of the device by you or your facility.

Description of Incident

This section requests tombstone information concerning the incident, including, the date of occurrence, whether it was reported to a company representative, the name and title of the user of the device, and patient outcome.

In field 19 you should provide the full details of the incident, including as much information as is known about the incident. This includes, what happened, when it happened, to whom it happened, was contamination or lack of sterility involved, etc.

In field 20 you should include any comments or additional information. This may include additional relevant tests/lab data, relevant medical history, descriptions of other types of medical therapy(ies) and medical product(s) in use by the patient during the time the incident occurred.