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The Age·3 min read·medium

Medical device one of many Australian products under scrutiny due to loose TGA approval process

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Henrietta Cook
Medical device one of many Australian products under scrutiny due to loose TGA approval process
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An investigation into the Australian Therapeutic Goods Administration reveals significant safety flaws in medical devices, specifically the Euky Bear humidifier. Parents have reported severe burns and overheating incidents, highlighting a lack of rigorous oversight for consumer medical products.

Why it matters

It exposes systemic failures in medical device regulation that directly impact consumer safety and public health.

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Age reporter Henrietta Cook was burnt using the Euky Bear. Simon Schluter Save You have reached your maximum number of saved items.

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Share A A A An investigation into medical devices reveals alarming flaws in both the machines we put in our bodies and the system that oversees them. See all stories . We were in the trenches. My seven-month-old baby had croup and his little body rattled through the night as he barked like a seal. Like many desperate parents wanting a solution, I drove to the nearest pharmacy.

In the third aisle, I thought I’d found the solution: a bulky, plastic humidifier called the Euky Bear.

An image of a blonde, sleeping baby graced the cardboard packaging, alongside the words “natural all-night relief from the symptoms of cold and flu ”.

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