Fields marked with an asterisk [ * ] are mandatory.


    1. Medical device

    *Medical device name


    Number of devices involved in the incident


    Serial number / lot number


    Expiry date


    Method of use


    Duration of use


    Other devices or accessories used with the device concerned by the report


    What is the current location of the device?




    2. Information about the person affected by the medical incident (*Complete at least one field)

    *Initials


    Number of patients affected by the incident


    *Age


    *Sex


    Health condition




    3. Incident description

    *Describe what went wrong with the device (if applicable) and the health consequences (if applicable), including clinical signs, symptoms, conditions and any impact on the overall state of health


    *Date of onset of symptoms – from


    *Date of onset of symptoms – to


    Actions taken by the patient or user as a result of the incident




    4. Details of the person reporting the incident (*Complete at least one field)

    Full name


    Address


    *E-mail


    *Phone number


    Role of the person reporting the incident: Professional user / Lay person / Patient / Other, please specify



    5. Additional information if the report is submitted by a healthcare professional

    Profession


    Healthcare facility address









    Consents

    *Information on the processing of personal data:
    The processing of personal data related to a serious incident by the recipient of the report must be carried out in compliance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ EU L 119 of 04.05.2016, p. 1, as amended). The person reporting a serious incident is required to pseudonymise the personal data of the patient or patients concerned by the report. Where the person submitting the report is the natural person affected by the serious incident (the patient), submission of the report constitutes consent to the processing of the personal data provided in the form by the recipient of the report indicated in Section 2 of the form, who is the controller of the personal data. If the natural person affected by the serious incident (the patient) who submits the report does not consent to the processing of their personal data by the recipient of the report, they shall submit the report only to the President of the Office, requesting that it be forwarded to the recipient of the report after the reporting person's data have first been pseudonymised. A reporting person who is a natural person has the right to access their personal data and the right to have inaccurate or incomplete data corrected or deleted. Data shall be corrected and deleted as soon as possible and no later than within 60 days of the submission of a request by the data subject. Personal data shall be stored in a form that permits identification of data subjects for no longer than the periods referred to in Article 10(8) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ EU L 117 of 05.05.2017, p. 1, as amended). Information on the processing of personal data by the President of the Office is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (http://urpl.gov.pl/pl/daneosobowe).

    I consent to the processing of the personal data I have provided for the purpose of receiving marketing information from Diagnosis S.A. concerning the products and services of Diagnosis S.A.

    I consent to Diagnosis S.A., with its registered office in Białystok, sending commercial information electronically to the e-mail address provided by me, within the meaning of Article 10(1) of the Act of 18 July 2002 on the Provision of Services by Electronic Means.

    I consent to Diagnosis S.A., registered with the District Court in Białystok, 12th Commercial Division of the National Court Register (KRS), under KRS number 0000431765, Tax Identification Number (NIP): 542-27-65-590, share capital: PLN 603,000, with its registered office in Białystok at ul. gen. W. Andersa 38A, 15-113 Białystok, using telecommunications terminal equipment and automated calling systems for direct marketing purposes.


    CONFIRM AND SUBMIT