This study is conducted globally. The aim of this observational study is to investigate the incidence of specific adverse drug reactions associated with the use of recombinant factor XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect.

The study will aim at observing all patients exposed to NovoThirteen® in the EU, and additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.

Inclusion Criteria:

• Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)
• Able and willing to provide signed informed consent (or patient's legally acceptable representative (LAR) consent, if applicable), as required by local ethics committee, governmental or regulatory authorities
• Congenital FXIII A-subunit deficiency
• Actual or planned exposure to rFXIII

This observational study will enroll patients with congenital FXIII A-subunit deficiency for whom the decision to treat with rFXIII has been made and who are willing to provide informed consent (or patient's legally acceptable representative (LAR) consent, if applicable).