Device Events

07/11/2024

Lead found in traditional tampons and arsenic found in organic tampons. Pick your poison?

More than 9,000 adverse-event reports involving tampons have been sent to the FDA over the past 15 years, with 78% of those reports coming since the start of 2019, according to data from Device Events, a company that tracks medical-device adverse-event reports. That’s an unusually high number, considering that consumer-product issues often fly under the radar because consumers don’t know how to report problems, Madris Kinard, CEO of Device Events and a former medical-device official at the FDA, told MarketWatch. The number of tampon-related adverse events is also probably “very, very underreported,” Kinard said, because most people who encounter a problem with a tampon will likely just throw it away or switch brands rather than pursuing the issue.

New research finding toxic metals such as lead and arsenic in tampons underscores longstanding gaps in oversight of the products, some women’s health...

05/13/2024

Madris Kinard, a former FDA manager who founded Device Events, which analyzes FDA data, said it defies belief that Johns Dental never received a complaint worthy of relaying to the FDA.

"That's a red flag for me. If I don't see a single report to the FDA, I typically think there is something going on," Kinard said. "When they don't report, what you have is devices that stay on the market much longer than they should. And patients get harmed."

Johns Dental Laboratories stopped making the Anterior Growth Guidance Appliance last year after a KFF Health News-CBS News investigation into allegations of patient harm.

03/03/2024

Navigating the Challenges in Device Safety: Sens. Dick Durbin and Richard Blumenthal sent a letter noting how the agency missed opportunities to protect the public from faulty medical devices, citing reporting by ProPublica and the Pittsburgh Post-Gazette.

02/29/2024

Device Events' easy to use software helps to reduce the time and energy it takes to research adverse events related to a medical device. Don't waste time! Check out Device Events Today! ⁠
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Dive into the details, including adverse event reports, at www.deviceevents.com

02/27/2024

Your insights matter. Dive into the details, including adverse reports, at www.deviceevents.com⁠⁠⁠⁠

02/27/2024

This! The FDA doesn’t have good information on tattoo inks because they don’t regulate that space. One of my former FDA co-workers told me they wished they could. They get reports of harm and have no oversight. Be informed and keep your family history and your own health history in mind with anything you put in your body. There are metals in some of the inks that are required to be disclosed if they are in a medical device but not in tattoo inks. These inks can migrate to your lymph nodes. When you get a tattoo removed it forces your body to process more of that ink at once…it is accelerating the process to clear the inks and there isn’t sufficient evidence or long term studies to show whether autoimmune issues can be exacerbated as part of the process. As with devices, drugs, supplements…some people have no issues, of course. I’m not saying you will. Just know the strain it can put on your health.

02/25/2024

Exciting update: Our latest addition to Device Events includes s*x, age, and race/ethnicity data—information concealed for 25+ years is now accessible, transforming the landscape of informed decision-making. 💻🔍 ⁠
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Dive into the details, including adverse reports, at www.deviceevents.com⁠
240-424-8562⁠⁠⁠⁠

02/23/2024

This FDA slide was used by one of their top scientists to describe how many malfunctions can occur before a death or injury report is sent to the FDA. Contact Device Events so we can show you how to identify potentially risky devices that may not yet have caused an injury or death.⁠
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240-424-8562⁠
deviceevents.com⁠⁠⁠⁠

02/21/2024

Unlock a proactive financial strategy with our comprehensive service! Clear and cost-effective access to medical device issues reported to the FDA.⁠
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Dive into the details, including adverse reports, at www.deviceevents.com⁠⁠⁠⁠

02/19/2024

With Device Events, you can filter reports based on your needs. Whether it's physician insights, risk manager reports, or biomedical engineer submissions, we've got you covered.⁠
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Dive into the details, including adverse reports, at www.deviceevents.com⁠⁠⁠⁠

02/17/2024

Use the same software used by ProPublica and other leading publications to identify adverse event signals.⁠
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Dive into the details, including adverse reports, at www.deviceevents.com⁠⁠⁠⁠

02/15/2024

Olympus High Flow Insufflation Unit recalled due to over-inflation concerns, posing serious health risks. www.deviceevents.com empowers you to research adverse reports on medical devices.⁠
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Dive into the details, including adverse reports, at www.deviceevents.com⁠⁠⁠⁠

02/13/2024

Behind the Billion-Dollar Acquisition: Medtronic's HeartWare Venture Turns Sour. A once-leading innovator in cardiac tech, the miniaturized heart pump faces lawsuits, recalls, and investigations.⁠
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Read the entire article: https://www.startribune.com/how-medtronics-billion-dollar-heartware-device-went-bust/600188914/⁠
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Dive into the details, including adverse reports, at www.deviceevents.com⁠⁠⁠⁠

02/11/2024

Device Events allows you to access the entire database swiftly, saving time and increasing efficiency.⁠
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Dive into the details, including adverse reports, at www.deviceevents.com⁠⁠⁠⁠

02/09/2024

Elevate your knowledge with our service for a proactive and informed approach to healthcare management.⁠
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Dive into the details, including adverse reports, at www.deviceevents.com⁠⁠⁠⁠

02/07/2024

Hamilton Medical Inc. recalls HAMILTON-C1, C2, C3, T1 ventilators due to software issues. Continuous use beyond 91 days in neonatal patients may lead to unexpected stops.⁠
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Dive into the details, including adverse reports, at www.deviceevents.com⁠⁠⁠⁠

02/05/2024

Learn how Device Events helped reporters to identify the device issues. Unveiling the hidden crisis: Philips Respironics' decade-long silence on device issues. Thousands reported 'black particles', contamination, and more. Discover the shocking truth behind the recalled machines – a story of withheld warnings and potential health risks.⁠
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Read the entire article: https://www.propublica.org/article/philips-kept-warnings-about-dangerous-cpaps-secret-profits-soared⁠
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Dive into the details, including adverse reports, at www.deviceevents.com⁠⁠⁠⁠

02/03/2024

Device Events empowers you to swiftly find patterns and insights, ensuring a proactive approach to healthcare management.⁠
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Dive into the details, including adverse reports, at www.deviceevents.com⁠⁠⁠⁠