reporting form, the online option, and the instructions for reporting clearly require reading skills and knowledge above the levels possessed by many consumers. For example, the form uses terms like “relevant history,” “congenital anomaly,” “concomitant products,” “event abated,” and “labeled strength” (FDA, 2003o). The agency urges consumers who want to report an event to have their physician complete the form.

Both mandatory and voluntary reports involving devices are compiled in the Manufacturer and User Facility Device Experience database (MAUDE). After certain information is removed (e.g., patient age, facility name), the reports are made available in a searchable public database. FDA and manufacturers have access to the full reports to support their analyses.

Table 4.1 shows the number of adverse event reports received by FDA from late 1984 to 2004 by major category of reporter, requirement for reporting (mandatory or voluntary), and type of event as designated by the person reporting it. The great majority of reports in MAUDE are submitted by manufacturers. One of the most notable trends shown in the table is the shift of adverse event reports to the alternative summary reporting option after its introduction by FDA in 1995. In recent years, such summary reports have accounted for more than half of total reports, for example, nearly 98,000 of the almost 152,000 reports received in 2004. The sizeable increase in adverse event reports (primarily injuries and malfunctions) from 1992 through 1994 has been attributed, in part, to reports of problems with silicone breast implants, which account for almost one-third of all reports from manufacturers (GAO, 1997).

Mandatory user facility reports account for less than 3 percent of the reports in Table 4.1. This number is, however, somewhat deceptive because FDA attempts to eliminate duplicate reports from the statistics so that a facility report that goes to both FDA and the manufacturer (and then to FDA) is not counted twice. (Facilities are supposed to report to FDA directly only if an event involves a death or the manufacturer of a device is not known.) Voluntary reports from health care professionals and consumers also account for a small percentage of reports (about 3 percent each year).

Unlike some patient safety programs described later in this chapter, FDA does not require or encourage reports of close calls from user facilities. In contrast, manufacturers are required to report device-related malfunctions, including those that could cause a death or serious injury if they recurred. When close calls involve situations with the potential to recur and cause harm, reports of such events may provide valuable signals if manufacturer and FDA analysts are prepared to notice them.

FDA sometimes discovers deficiencies in manufacturer reporting of adverse events and product problems (or their systems related to such reporting) during quality systems inspections, through investigations of incidents, and in other ways. The agency typically responds with letters that



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