FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

More Post-Market Reviews for Devices in Australia Lead to Product Withdrawals

Dec. 15, 2017

Australia’s Therapeutic Goods Administration received 3,841 adverse event reports relating to medical devices in 2016, compared with 3,359 in 2015. Most of the reports (81 percent) were made by medical device sponsors.

The number of reports by doctors also spiked, increasing to 88 reports in 2016 from 54 in 2015.

During 2016, the agency conducted post-market reviews on heater-cooler devices, insulin pumps, prosthetic aortic heart valves, urogynecological meshes, self-test/point-of-care urine hCG pregnancy tests, chest drains, breast implants, gloves and chlorhexidine-based disinfectants.

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