{"id":22230,"date":"2023-12-21T07:53:40","date_gmt":"2023-12-21T12:53:40","guid":{"rendered":"https:\/\/medicarereport.org\/?p=22230"},"modified":"2023-12-21T07:53:41","modified_gmt":"2023-12-21T12:53:41","slug":"deep-flaws-in-fda-oversight-of-medical-devices-and-patient-harm-exposed-in-lawsuits-and-records","status":"publish","type":"post","link":"https:\/\/medicarereport.org\/?p=22230","title":{"rendered":"Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records"},"content":{"rendered":"\n<p>(By Fred Schulte and Holly K. Hacker for KFF Health News)<\/p>\n\n\n\n<p>Living with diabetes, Carlton \u201cPeeWee\u201d Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.<\/p>\n\n\n\n<p>The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.<\/p>\n\n\n\n<p>The 59-year-old died suddenly on May 17, 2020, because \u2014 his family believes \u2014 the pump malfunctioned and delivered a fatal overdose of insulin.  Continue reading <a href=\"https:\/\/kffhealthnews.org\/news\/article\/medical-device-malfunction-fda-oversight-patient-harm\/\" data-type=\"link\" data-id=\"https:\/\/kffhealthnews.org\/news\/article\/medical-device-malfunction-fda-oversight-patient-harm\/\">here&#8230;<\/a><\/p>\n\n\n\n<p class=\"has-small-font-size\">Kaiser Health News is a nonprofit national health policy news service that is part of the nonpartisan Henry J Kaiser Family Foundation.<\/p>\n\n\n\n<p><img loading=\"lazy\" decoding=\"async\" width=\"150\" height=\"17\" class=\"wp-image-21118\" style=\"width: 150px;\" src=\"https:\/\/medicarereport.org\/wp-content\/uploads\/2023\/04\/image.png\" alt=\"\" srcset=\"https:\/\/medicarereport.org\/wp-content\/uploads\/2023\/04\/image.png 500w, https:\/\/medicarereport.org\/wp-content\/uploads\/2023\/04\/image-300x34.png 300w\" sizes=\"auto, (max-width: 150px) 100vw, 150px\" \/><\/p>\n\n\n\n<p class=\"has-small-font-size\"><strong>Notice:<\/strong>&nbsp;The link provided above connects readers to the full content of the posted article. The URL (internet address) for this link is valid on the posted date; medicarereport.org cannot guarantee the duration of the link\u2019s validity. Also, the opinions expressed in these postings are the viewpoints of the original source and are not explicitly endorsed by AMAC, Inc.; the AMAC Foundation, Inc.; or medicarereport.org<\/p>\n","protected":false},"excerpt":{"rendered":"<p>(By Fred Schulte and Holly K. Hacker for KFF Health News) Living with diabetes, Carlton \u201cPeeWee\u201d Gautney Jr. relied on<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[31,14],"tags":[76,1041,467],"class_list":["post-22230","post","type-post","status-publish","format-standard","hentry","category-fda","category-medical-technology","tag-fda","tag-medical-devices","tag-patient-safety"],"_links":{"self":[{"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/posts\/22230","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/medicarereport.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=22230"}],"version-history":[{"count":1,"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/posts\/22230\/revisions"}],"predecessor-version":[{"id":22231,"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/posts\/22230\/revisions\/22231"}],"wp:attachment":[{"href":"https:\/\/medicarereport.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=22230"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medicarereport.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22230"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medicarereport.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22230"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}