Something is not right? Tell us.

In a medical emergency, call 911 or go to the nearest emergency department. If you have a concern after a procedure, contact your surgeon first: only your care team can examine you.

Patients, family members and healthcare professionals can report any problem, complaint or side effect that may be related to FixNip NRI, including a defect in the device, its packaging or labelling:

• E-mail: safety@fixnip.ca
• Mail: MedTechInvest Canada, 4789 Yonge St., Suite 805, Toronto, ON M2N 0G3, Canada

Please tell us, as far as you know them:

1. what happened and when;
2. the date of the procedure and the name of the surgeon or clinic;
3. the lot or serial number of the device, if you have it (it is on the Implant Card your surgeon gives you after the procedure, and in the surgical record);
4. how we can reach you.

Please give only the health information needed to understand the problem. We handle it in accordance with our privacy policy.

You may also report a suspected device-related problem to the manufacturer, using the contact details in the Patient Information Leaflet and on your Implant Card: FixNip Ltd., 13 Bareket Industrial Park St., Caesarea 3079544, Israel, telephone +972 4 867 5090, e-mail info@fixnip.com.

• We confirm receipt and record the report as required by the Medical Devices Regulations.
• We investigate it together with the manufacturer, FixNip Ltd., and may contact you or, with your permission, your surgeon for further information.
• Where the Medical Devices Regulations require it, we and the manufacturer report the incident to Health Canada: within 10 days after we become aware of it if it has led to a death or a serious deterioration in health, and within 30 days if it has not but could do so if it happened again. A final report follows once the investigation is complete.
• If a corrective action or a recall becomes necessary, we notify Health Canada within the deadlines of the Medical Devices Regulations and inform the physicians and facilities that received the device directly, so that they can contact their patients. Health Canada also publishes recalls at recalls-rappels.canada.ca.

You can also report a problem with a medical device directly to Health Canada, whether or not you have contacted us:

• Report a medical device problem (patients and consumers)
• MedEffect Canada: all reporting options

Health Canada publishes recalls and safety alerts at recalls-rappels.canada.ca.

Hospitals are required to report serious medical device incidents to Health Canada within 30 days of documenting them. We ask physicians to inform us as well, so that the manufacturer can investigate.

For questions about this website, see the contact page. For questions about your personal information, contact our Privacy Officer through the privacy policy.