SUR - Summary product experience report

The Summary Product Experience Report message can be divided into two separate parts. Part 1 consists of a Facility segment which identifies the reporting organization, a Product Summary Header segment which provides summary information about the products and manufacturers, and a Product Detail Country segment which provides country specific product identification and marketing information. Part 2 consists of a repeating series of segments. These segments could be used to represent data about each model of a medical device (Part 2 of FDA Form 3417, for example). The Product Summary Header segment provides manufacturer's data, under which repeating sets of Facility segments (representing multiple manufacturing sites), a Product Detail Country segment (representing marketing and product identification data) and the Note segment (for other commentary) may follow. Finally, the Encapsulated Data (ED) segment can be used to transmit images of documents, including any of the MIME (Multimedia Internet Mail Extension) support formats such as JPEG, GIF, and FAX.