And there is this, but keep in mind, this is concerning all adverse events related to
any medical product.
Underreporting
Another major concern with any spontaneous reporting system is underreporting of adverse events (16, 30-32). It has been estimated that rarely more than 10% of serious ADRs, and 2-4% of non-serious reactions, are reported to the British spontaneous reporting program (30).
A similar estimate is that the FDA receives by direct report less than 1% of suspected serious ADRs(32).This means that cases spontaneously reported to any surveillance program, which comprise the numerator,
generally represent only a small portion of the number that have actually occurred. The effect of underreporting can be somewhat lessened if submitted reports, irrespective of number, are of high quality.
http://www.fda.gov/medwatch/articles...nt/postrep.htm