Medical incidents
Form

Step 1: Data of the person where the incident occurred

In whom did the incident occur? at yourby a professional user (doctor/medical staff)at another person Initials* Gender* WomanManNo data Age Body weight (kg) What part(s) of the body is involved in the incident?

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Step 2: Information about the incident

Description of the incident*. Date of the incident What were the consequences of the incident? DeathHospitalizationExtension of hospital stayAdditional operationDoctor's visit/additional medicationOther Whether the observed symptoms / event:Completely gonePersist in unchanged intensity/formThere has been an improvementThere has been a worsening of symptomsNo informationOther

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Step 3: Medical device information

Name* Series number Medical indications (for what reason the device was used) Additional information about the subject of the incident, e.g. allergies, other diseases, results of additional tests related to the reported incident Can the product be returned to PPF Hasco-Lek S.A.?

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Step 4: Details of the reporting person

First and Last Name* Phone number* Email address* I confirm that I have read the information regarding the processing of personal data*.

Information of the personal data controller

In accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27.04.2016. on the protection of individuals with regard to the processing of personal data on the free flow of such data and the repeal of Directive 95/46/EC (hereinafter referred to as RODO), we would like to inform you that the Administrator of your personal data is PPF Hasco-Lek S.A., located in Wrocław, ul. Żmigrodzka 242e, 51-131 Wrocław.

Your personal data, i.e. Name, surname, address, telephone number, e-mail address, health data will be processed for purposes:

Ensure high standards of quality and safety of medicinal products and, in particular, monitor the safety of medicinal products, including keeping a register of reports of individual cases of adverse reactions to medicinal products and reporting individual cases of adverse reactions to medicinal products to the competent authorities: - health data will be processed on the basis of Art. 9 paragraph. 2(i) RODO, i.e.. processing is necessary for reasons of public interest in the field of public health in the form of ensuring high standards of quality and safety of medicinal products on the basis of a legal provision, i.e. based on art. 36e para. 1 of the Pharmaceutical Law; - other personal data will be processed on the basis of Art. 6 sec. 1(c) RODO, i.e.. processing is necessary for the fulfillment of the Administrator's legal obligation under Art. 36e para. 1 of the Pharmaceutical Law; to contact the treating physician and obtain additional information in connection with adverse reactions to the medicinal product from the treating physician - on the basis under Art. 6 sec. 1(c) RODO, i.e.. processing is necessary for the fulfillment of the Administrator's legal obligation under the law. Art. 36e para. 1 of the Pharmaceutical Law; To establish, assert or defend possible claims between you and the Administrator - with regard to health data on the basis of Art. 9 paragraph. 2(a) of the RODO, i.e. processing is necessary for the establishment, investigation or defense of claims; for other ordinary data under Art. 6 sec. 1(f) RODO, i.e.. on the basis of the legitimate interest pursued by the Administrator, which is the possibility of pursuing claims. No decisions will be made against you by automated means, including following profiling.

Provision of data is voluntary. Your personal data may be disclosed to the following entities: Your attending physician (if you consent to be contacted by your attending physician), IT service providers, entities providing consulting, legal services; also to entities and authorities authorized to process such data under the law, in particular the President of the Office of Medicinal Products, Medical Devices and Biocidal Products, the European Medicines Agency and other competent authorities of the European Union member states where the Administrator has obtained marketing authorization for a medicinal product.

Personal data will be processed for the period necessary for the purposes for which the data are processed or until an objection is raised (if the basis of processing is the legitimate interest of the Administrator) or until consent is withdrawn (if the basis of processing is the consent granted) - whichever occurs first. After the above period, personal data will be kept for a period of 10 years from the expiration date of the batch of medicinal product for which the application was submitted or until the statute of limitations for claims.

You have the following rights: the right to object, to access the content of your personal data, to correct, delete them (the so-called "Right to be forgotten"), the right to limit processing, the right to their portability as well as the right to lodge a complaint to the supervisory authority - the President of the Data Protection Authority, (web address: https://uodo.gov.pl/pl/p/kontakt ), if you consider that our processing of your personal data is in violation of the law.