Device Events

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.

Tampon toxic-metals scare follows years of warnings about oversight gaps New research finding toxic metals such as lead and arsenic in tampons underscores longstanding gaps in oversight of the products, some women’s health...

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."

FDA said it "never" inspected dental lab that made controversial AGGA device 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.

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.

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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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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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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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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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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Use the same software used by ProPublica and other leading publications to identify adverse event signals.⁠
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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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