Commission Implementing Directive 2012/25/EUShow full title

ANNEX I Initial Report for suspected serious adverse events or reactions

1. Reporting Member State

2. Report identification number: country (ISO)/national number

3. Contact details of the reporter (competent authority or delegated body in the reporting Member State): telephone, e-mail and, when available, fax

4. Reporting centre/organisation

5. Contact details of coordinator/contact person (transplant/procurement centre in the reporting Member State): telephone, e-mail and, when available, fax

6. Reporting date and time (yyyy/mm/dd/hh/mm)

7. Member State of origin

8. National donor identification number, as communicated under Article 6

9. All Member States of destination (if known)

10. National recipient identification number(s), as communicated under Article 6

11. Onset date and time of serious adverse event or reaction (yyyy/mm/dd/hh/mm)

12. Detection date and time of serious adverse event or reaction (yyyy/mm/dd/hh/mm)

13. Description of serious adverse event or reaction

14. Immediate measures taken/proposed