outline the problems and needed corrections. Only rarely are criminal penalties sought.1 FDA staff could not cite cases in which user facilities had been penalized for failure to comply with their mandatory reporting obligations (personal communication, Thomas P. Gross, M.D., Director, Division of Postmarket Surveillance, CDRH, January 28, 2005).

Table 4.2 shows the number of reports submitted that identified adverse events as involving patients under age 21. (These data were supplied by FDA from their internal database. As noted above and in Chapter 3, the public database does not include information on age or birth date.) The table shows no entries for the summary reporting option because this option does not require information on patient age.

The numbers presented in Table 4.2 are undoubtedly an undercount of all reported events that involved children (leaving aside all actual events). The fields on the reporting form that request birth date or age information are sometimes not completed, perhaps because the information is not immediately available to the reporter. In FDA’s analysis of reports of patient entanglement in hospital bed side rails—an event associated with high rates of death (65 percent of reports) and injury (23 percent of reports)—age was not included for 36 of 111 of the reports in MAUDE (Todd et al., 1997a,b). Of the 75 cases for which age data were provided, 5 percent involved patients under age 17. Even if event reporting were more complete, it would be difficult to assess the extent of a problem without knowing the population at risk (the denominator problem as discussed elsewhere in this report and in Appendix D).

Box 4.1 presents several excerpts from reports to FDA of adverse events that involved children. The examples (which include the full narrative text of the reports) illustrate that reports vary greatly in the amount and usefulness of the information provided. Some offer a relatively clear picture of an event; others are incomplete. Reports nearly always focus on the immediate circumstances surrounding an event and thus are limited in the extent to which they point to contributing system factors, for example, understaffing.

These examples of reports make evident some of the challenges in investigating adverse event reports, especially when the investigator is organizationally removed from the event, as is usually the case for manufacturer or FDA staff. For example, although manufacturers (and FDA) can often follow up with reporters to collect additional information, manufacturers may not have access to the device for inspection, and important information


To cite one noteworthy exception, in 2003, Endovascular Technologies, a subsidiary of a major device manufacturing company, entered guilty pleas on 10 felony charges involving failure to submit problem reports to FDA and paid more than $92 million in civil and criminal penalties to settle the case (Bren, 2003; Hilzenrath, 2003; Jacobs, 2003; Ostrov et al., 2003). The unit admitted to failing to report 2,600 incidents of serious adverse events (including 12 unreported deaths and 57 unreported emergency surgeries) or malfunctions between 1999 and 2001. Instead, it reported only 172 malfunctions. FDA learned of the suppressed reports through an anonymous letter from concerned company employees.

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