13: Making Sense of Medical Device “Adverse Events” with Madris Kinard 


Manage episode 294040495 series 2419713
By Clay Hodges and Attorney Clay Hodges. Discovered by Player FM and our community — copyright is owned by the publisher, not Player FM, and audio is streamed directly from their servers. Hit the Subscribe button to track updates in Player FM, or paste the feed URL into other podcast apps.

We all try to be conscious of what we eat, so shouldn’t we be conscious of what medical devices are implanted in our bodies? Unfortunately, most people can’t make sense of the millions of adverse events filed with the FDA.

Today’s guest, Madris Kinard, left the FDA after years of seeing patients not get the data they need and started Device Events. Device Events is a subscription-based service that provides stakeholders with accessible information on products. Join Clay Hodges in this interview for more information on the gaps in the FDA, changes being made, and what Device Events does differently.

Show Highlights:

  • How Madris started Device Events and the primary purpose of the service
  • What was not working with the FDA that made this service needed
  • How does Device Events work and what makes it a valuable service
  • What could the FDA do to make data more accessible
  • The timeline and process of recalls
  • Why devices should stop being put on the market based on a grandfathered device
  • Public panels the FDA has held for individuals to express issues
  • Why it’s important to know what materials are in devices
  • The medical devices Madris is currently examining
  • Issues with current dental implants and reported injuries
  • Problems with breast implants and symptoms they cause




15 episodes