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Monitoring is a series of activities designed to continuously evaluate all product safety information, including suspected adverse reactions, and to ensure, for all medical devices on the market, a favorable benefit/risk ratio for the population.
In line with this general definition, the main purposes of Monitoring are:

  • prevention of harm caused by adverse reactions in humans
  • promoting safer and more effective use of medical devices, especially by giving timely information about their safety to patients, healthcare professionals and the general public.


What is an adverse reaction?

An adverse reaction is a harmful and unintended reaction following:

  • the use of the medical device under normal conditions of use
  • medication errors
  • improper uses not in compliance with the indications given by the manufacturer, including overdose and misuse of the medical device 
  • occupational exposure


What to do in case of a suspected adverse reaction?

The spontaneous reporting of suspected adverse reactions can be carried out either by patients or healthcare professionals, through the sending of specific ministerial forms to the Monitoring Managers of local healthcare companies, hospitals, nursing homes and the Ministry of Health.


For patients and healthcare professionals

You'll find the form to complete online by clicking here: Rapporto di incidente da parte di operatori sanitari al Ministero della Salute.

The files in PDF format generated by following the above procedure shall be sent to the Ufficio 5 della Direzione generale dei dispositivi medici e del servizio farmaceutico, at this email address: dgfdm@postacert.sanita.it

In case you want to make a complaint about one of our products, please fill out the form below or send an e-mail to complaints@prodecopharma.com including your Name, Surname and the product reference.

Report a suspected adverse reaction

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