Faulty Postmarket Tracking Continues to be a Problem

In the advent of FDA's Postmarket Transformation Initiative and recent highly publicized recalls, companies need to make sure they have efficient and effective device tracking systems in place. The article in the Times cites the delay in the recall of a hernia patch, manufactured by Davol Inc., a subsidary of C.R. Bard. In this instance, Davol failed to "accurately" report the potential severity of the device complaints to FDA, and agency inspectors found "inconsistencies" in how the company tracked the device complaints, according to the article.