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FDA Hiding Reports of Defective Medical Devices from Doctors


When Dr. Douglas Kwazneski was helping a fellow surgeon remove an appendix, something went wrong with the medical stapler he was using. The device locked up. Instead of sealing and cauterizing the wound, Kwazneski was unable to get the device to function properly. Later, he looked up the make and model of the device in the database that the FDA uses to inform doctors about the potential dangers of specific devices. He found no entry concerning the particular device he was using. Perplexed, Dr. Kwazneski inquired as to his colleagues’ experiences with the device. Many told him that they had problems with the device and, as required by law, reported it to the FDA.

The FDA keeps a massive database on device failures to inform doctors about potential dangers that can happen during surgeries. The database, entitled MAUDE, is a matter of public record and accessible by anyone. It is especially valuable to doctors who are required to anticipate problems before they happen. So why wasn’t information pertinent to this particular medical stapler anywhere to be found in the database despite widespread concern over its safety?

The FDA has a Second Database 

From 2016, over one million defective medical device reports have been sent to a black hole database that is only searchable by members of the FDA. The database itself is such a well-kept secret that even those at the FDA claim they have never heard of such a thing. Nonetheless, a spokesperson for the FDA confirmed that the database existed and that certain medical devices qualified for an exemption. But exactly how one medical device qualifies for an exemption while another does not is the matter of widespread speculation.

The FDA has assured the public that the only entries that can be found in this database are those that doctors and medical professionals already have knowledge of. But in the case of this one medical stapler, that turned out not to be the case.

This database contained information on over 100 medical devices that caused serious injury to patients or malfunctioned during surgeries. Now, it’s not just the public who is concerned about these problems, doctors are as well.

By not making this information available to the public, doctors are not only putting their patients in danger, but they themselves can now be targeted for malpractice lawsuits for errors caused by defective medical devices.

The registry exemption which allows for “alternative” summary reporting seems to be a system without oversight, regulations, or public knowledge. The FDA has promised to remove the exemption for medical staplers but did not go so far as to say that all defective medical device reports would be made known. Nonetheless, without this information, patients are at risk.

Talk to a St. Petersburg Medical Malpractice Attorney 

If you have been injured by a medical device or a negligent doctor, the St. Petersburg medical malpractice attorney at Masterson & Hoag, P.A. can help you recover damages for your injuries. Give us a call to set up an appointment today.




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