Adverse drug events and incidents with medical devices and other healthcare products
An adverse drug event or an incident with another healthcare product (e.g. blood product, tissues, cells or a medical device) refers to a known or unknown event or error occurring in connection with healthcare activities or in connection with the supply of or information about medicines.
An adverse event or 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 drug events and adverse drug reactions (side effects)
Adverse drug events could be dosage errors, incorrect administration of the medicine or mix-ups of product names or packaging.
In Denmark, healthcare professionals in the primary and secondary sectors have an obligation to report adverse drug events and incidents with medical devices and other healthcare products.
Adverse drug events must be reported to the Patient Complaints Centre: Danish Patient Safety Database
In addition, doctors can report adverse drug events to the Danish Medicines Agency using an e-form in Danish: