Adverse drug events and incidents with medical devices and other healthcare products

Updated 16 June 2016

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, it is mandatory for healthcare professionals in the primary and secondary sectors to report adverse drug events and incidents with medical devices and other healthcare products.

Medicine

Adverse drug events must be reported to the National Agency for Patients' Rights and Complaints (Danish Patient Safety Database).

In addition, doctors can report adverse drug events to the Danish Medicines Agency using an e-form in Danish: Problems associated with the use of medicine, medical devices or suspicion of drug misuse (e-form in Danish only).

Blood and blood products, tissues and cells as well as medical devices

Adverse incidents involving blood and blood products, tissues and cells as well as medical devices must be reported to the Danish Medicines Agency:

Side effects and adverse incidents involving blood and blood products

Side effects and adverse incidents involving tissues and cells

Medical devices

Adverse incidents involving medical devices can be reported using a form in Danish, which is available here: medicinskudstyr.dk - Incident reporting.

You can also use the Danish e-form below to report problems associated with the use of medicine, medical devices or suspicion of drug misuse: Problems associated with the use of medicine, medical devices or suspicion of drug misuse (e-form in Danish only).

Field safety notices sent by medical device manufacturers

See the field safety notices sent by medical device manufacturers on the website medicinskudstyr.dk (not all are in English).

The field safety notices are sent by medical device manufacturers, or their representatives, to customers and/or users of medical devices.

The notices generally communicate information about correct use, the need for modification, or instructions to dispose of or return medical devices.