Adverse Event Reporting

TR-005 · HK-unique timeframes

What Must Be Reported

Report any event involving an MDACS-listed device that resulted or could result in:

• Death or serious injury to patient, user, or other person
• Near-incident (potential serious harm if recurrence)
• Serious public health concern

Reporting Timeframes

Situation	Timeframe
Death / serious injury / serious public health concern	Within 10 calendar days of LRP becoming aware
Other reportable/potentially reportable events	Within 30 calendar days of LRP becoming aware

Process

1. LRP becomes aware of event
2. LRP investigates (with manufacturer if needed)
3. Submit preliminary report to MDD within applicable timeframe
4. Complete investigation → submit final report with findings and recommendations
5. MDD reviews and may request further information or initiate its own investigation

Reports are submitted via the MDIS portal.