Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance)
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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]
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