about the device (e.g., brand and model number and even manufacturer) may not have been documented. A later section of this chapter returns to these and other limitations of adverse event reporting programs.

When FDA receives an adverse event or device malfunction report from a manufacturer or other party, it (actually a contractor) checks the report, codes certain information if it has not been coded already by the reporter, and enters the report into the database.² FDA has developed codes for both clinical outcomes (e.g., cerebral hemorrhage) and device outcomes (e.g.,