According to the Act of 7 April 2022 on medical devices, a medical incident may be reported to the President of the Office by anyone who has become aware of a medical incident on the territory of the Republic of Poland.
Medical incident
Any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device.
Serious medical incident
Any incident that directly or indirectly led, might have led or might lead to any of the following:
-
the death of a patient, user or other person,
-
the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
-
a serious public health threat.
Medical incidents after the use of a medical device for which Saventic Health Sp. z o. o. is a manufacturer can be reported by completing the attached form and then submitting it in one of the following ways:
-
by e-mail: im_saventicmed@saventic.com
-
by registered mail or courier to the following address:
Saventic Health
ul. Władysława Łokietka 5,
87-100 Toruń
Serious Incident Report Form
Please send a copy of the incident report to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, by e-mail (address: incidenty@urpl.gov.pl), by fax (no. 22 492 11 29), by registered letter or by courier (ul. Ząbkowska 41 , 03-736 Warsaw).
Please provide as detailed a description of the medical incident as possible. Any information may turn out to be very important in order to determine the cause of the incident and the relationship between the use of the medical device and the medical incident.
By reporting a medical incident, we collect information about the medical device, thanks to
which we increase its safety of use.
If you have any questions regarding reporting a medical incident, please contact us at the
following e-mail address: im_sara@saventic.com
Please be advised that the information you provide is treated as confidential. Your personal data will be processed by Saventic Health Sp. z o.o. based on the Act of May 10, 2018 on the protection of personal data and art. 6 sec. 1 lit. c and art. 9 sec. 2 lit. and EU Regulation 2016/679 of April 27, 2016 only for purposes related to the implementation of the obligation to monitor the safety of medical devices.