In the first half of the year, 18096 adverse reactions / events of medical devices were reported

Today (July 22), the office of Hubei food and Drug Administration issued the notice on the collection and evaluation of ADR reports of medical devices in June 2016 From January to June 2016, 18096 ADRs / events were reported in the whole province, and from June 2016, 4477 ADRs / events were reported in the whole province The details are as follows ------------------------------------------------------------------------------------------Food and Drug Administration of all cities, prefectures, municipalities directly under administration and Shennongjia Forest Region: In June 2016, 4477 ADRs / events were reported in the whole province, 1401 new and serious reports, accounting for 31.29% of the total reported in the same period, 381 serious reports, accounting for 8.51% of the total reported in the same period, and the review and evaluation rate of ADRs / events was 97.79%; 863 ADRs / events of medical devices were reported in the whole province, with the review and evaluation rate of 95.48% From January to June 2016, 18096 ADRs / incidents were reported in the whole province, an increase of 5.51% compared with the same period of 2015 311.1 cases were reported by one million people, and 34.11% of them were new and serious reports, among which 10 cities and prefectures accounted for more than 30%; 2071 cases were serious reports, accounting for 11.44% of the total reports in the same period, and the audit and evaluation rate was 95.02%, and less than 95% were Jingmen, Ezhou, Shiyan Enshi, Xiaogan, Xianning, Qianjiang, Tianmen, etc 2194 cases of adverse events of medical devices were reported in the whole province, an increase of 13.21% over the same period last year 37.72 cases were reported in a million population, with an audit and evaluation rate of 97.63% There are 4 cities and prefectures, including Xianning, Ezhou, Qianjiang and Yichang, which are lower than 95% From January to June 2016, 99.17% of the adverse drug reactions were reported at the county level, and 84.35% of the adverse drug events were reported at the county level See the attachment for details Annex: 1 Statistical table of adverse drug reactions / event reports collection and evaluation in cities, prefectures, municipalities directly under administration and Shennongjia forest region in June 2016 2 Statistical table of adverse drug reactions / event reports collection and evaluation in cities, prefectures, municipalities directly under administration and Shennongjia forest region in January June 2016 3 Statistical table for collection and evaluation of adverse event reports of medical devices in cities, prefectures, municipalities directly under the central government and Shennongjia forest region in June 2016 4.2016 statistical table for county level reports of adverse reactions / events of medical devices in cities, prefectures, municipalities directly under the central government and Shennongjia forest region in 1-6 2016 Hubei food and Drug Administration Office July 19, 2016