An adverse incident involving a medicinal product or other healthcare product (e.g. blood product, tissues, cells or a medical device) refers to a known or unknown incident or error occurring in connection with healthcare activities or in connection with the supply of or information about medicines.
An adverse incident is an event that causes or could have caused damage to the patient, and which is not the result of the patient's underlying condition.
A distinction is made between adverse incidents and side effects of medicines. Adverse incidents could be dosage errors, incorrect administration of the medicine or mix-ups of product names or packaging.
Healthcare professionals in the primary and secondary sector have a duty to report adverse incidents.
Incidents with medical devices
Incidents with medical devices must also be reported to the Danish Health and Medicines Authority. You can do so using the reporting form for incident reporting on our subsite www.medicaldevices.dk.
You can also use a special Danish e-form for reporting problems associated with the use of medicine, medical devices or suspicion of drug abuse. Please click the link below.
Form
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Problemer ved brug af medicin, medicinsk udstyr eller mistanke om misbrug (e-blanket)
