Q82 Will you report a serious adverse event?
Yes. We report qualifying adverse events and reactions to the relevant authorities as required and truthfully explain the situation and follow-up plan to you.
Adverse drug reactions, device-related adverse events, serious complications and similar events.
Measures for the Administration of Adverse Drug Reaction Reporting and Monitoring; Measures for the Administration of Medical Device Adverse Event Monitoring and Re-evaluation; Regulations on the Prevention and Handling of Medical Disputes.
Reporting is a regulatory duty, not a determination of liability. Personal information included in reports is handled under the Personal Information Protection Law.
If you suspect a drug- or device-related problem, retain packaging and medication records and seek prompt reassessment.