Materiovigilance is the system for monitoring adverse incidents involving medical devices on the market and preventing their recurrence. As a distributor, Hemera Medikal is obliged to pass product safety reports to the manufacturer and to the Turkish Medicines and Medical Devices Agency (TITCK), and we fulfil this obligation in full.
What should you report?
- Incidents in which a device caused or could have caused the death of, or serious deterioration in the health of, a patient or user
- Deviations of a device from its labelling, instructions for use or performance characteristics
- Suspected problems with packaging, sterility or expiry dates
How to report
- Take the device out of use and keep the label, serial or lot number and photographs.
- Fill in the Technical Service Request form on this site with the 'Safety report' option, or call our quality unit.
- Our quality manager will contact you within 24 hours at the latest and log the incident.
- Where necessary the report is forwarded to the manufacturer and TITCK; if a field safety corrective action (FSCA) applies, affected customers are notified in writing.
Recalls
For recalls or field safety notices initiated by the manufacturer, we contact every customer who purchased the lot concerned by email and phone; return or replacement is free of charge and fully recorded.
Contact
You can reach our quality unit for safety reports at kalite@hemeramedikal.com.tr or on +90 216 555 36 00. The confidentiality of reports is protected, and no sanction is applied to the person making a report.