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The Tobacco Product Events and Malfunctions (EM) ) domain is based on the Events General Observation general observation class and is used to represent device issues and/or events. 

There is more than one 1 approach to identifying tobacco product devices involved with these events/incidents. The method chosen will depend upon the granularity at which the applicant needs to track the tobacco product devices and will affect how the data are modeled. A tobacco product device can be identified as a single unit or its components can be separately identified. The level of granularity an applicant chooses will be influenced by whether the components will be replaced and/or tracked, and how tobacco product device/adverse event relationships and actions taken will be assessed.

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