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Faulty Postmarket Tracking Continues to be a Problem

An article in today's edition of the New York Times is further evidence of the increased scrutiny that the medical device industry has been facing in recent times. The piece questions how device companies react to product malfunction and how they're perhaps not moving fast enough to pull these devices from the market. It also ties the failure to recall a product with the inability to properly track and analyze device-related complaints.

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.

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