Division PART B Conclusions of Serious Adverse Reactions InvestigationF1

Tissue establishment

EU tissue establishment code (if applicable)

Report identification

Confirmation date (year/month/day)

Date of serious adverse reaction (year/month/day)

Unique donation identification number

Confirmation of serious adverse reaction (Yes/No)

Single European Code of tissues or cells involved in the confirmed serious adverse reaction (if applicable)

Change of type of serious adverse reaction (Yes/No) If YES, specify

Clinical outcome (if known)

• Complete recovery

• Minor sequelae

• Serious sequelae

• Death

Outcome of the investigation and final conclusions

Recommendations for preventive and corrective actions