This class contains those properties required for the reporting of product safety-related information (to include product defects) to a regulatory agency. It contains the intersection of the information required for four specific reports: MedWatch 3500, MedWatch 3500A, MedWatch 3500B, and VAERS-1. It is anticipated that subtypes will be created for these individual reports, which will add report-specific properties and constraints. This class is based in the Individual Case Safety Report (ICSR) series of standards. An ICSR is a report of information describing adverse event(s) / reaction(s) experienced by an individual patient. The event(s) / reaction(s) can be related to the administration of one or more medicinal products at a particular point in time. The ICSR can also be used for exchange of other information, such as medication error(s) that do not involve adverse events(s)/reaction(s).