Reporting of severe incidents of a medical device

What is an adverse event and a severe incident?

According to the regulations on medical devices, an adverse event is understood as any malfunction or deterioration in the properties or performance of the device marketed, including user error due to ergonomic properties, as well as any lack of information provided by the manufacturer and any undesirable side effect.

A severe incident, according to the regulations on medical devices, is an adverse event that directly or indirectly leads, could lead, or may lead to one of the following consequences:

1. death of a patient, user or other person,
2. temporary or permanent deterioration of the health status of a patient, user or other person,
3. serious threat to public health.

A user or patient should report any severe incident related to the device to the manufacturer and the competent authority of the member state in which the user or patient is located.

If you want to report a severe incident of a medical device to MEDITES PHARMA, please call us or write an email to:

Libuše Franová, the person responsible for vigilance

Mobile: +420 602 541 650

Email: libuse_franova@meditespharma.cz

Please provide:

• information about the medical device (trade name, batch number),
• information about the adverse event (exact description of the adverse event, number of patients affected),
• information about the patient (initials, gender, year of birth),
• your contact details (name and surname, telephone number, email).