China FDA logs more than 320,000 device adverse medical reports in 2015

Microscope

China FDA has released an updated tally of adverse event reporting for medical devices that found more than 320,000 incidents were noted in 2015 with 80% from users of medical equipment. A separate report linked 184 deaths to incidents involving devices.

The full report was not immediately available, but summaries were posted on the regulator's websites in English and Chinese with broad figures provided.

However, a separate report by China.org.cn said the 184 deaths were among 47,249 cases of "adverse effects" in 2015, citing the China FDA that said the figures represented a 15.2% rise from 2014. The variation between reported incidents and confirmed were not available.

The China.org.cn article said high-incident figures were noted in "polymer for medical use, syringes and puncturing instruments, medical dressings, physical therapy instruments, implants and artificial organs."

No particular companies or equipment types were identified in the releases or article.

In the English release, China FDA said the report "includes the general situation of medical device adverse event reporting, the statistical analysis of medical device adverse events, and the control measures for the safety risks of medical X-ray angiography equipment, external defibrillator and low frequency electromagnetic therapy equipment."

- here's the English China FDA release
- and the release in Chinese
- and a story from China.org.cn

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