There was no iMRI - related adverse event occurred.

无iMRI相关不良事件发生.

No severely adverse event was reported in both groups.

且两组均无严重不良事件的报告。

Adverse event rates during the off-treatment phase were similar between groups.

在非治疗期间不良事件发生率两组相似。

Application site reactions were the most commonly reported adverse event (16.1%).

用药部位反应是最常见的不良事件（16.1%）。

Application site reactions were the most commonly reported adverse event (16. 1%).

用药部位反应是最常见的不良事件（16.1%）。

If I am a manufacturer, what information must I submit in my individual adverse event reports?

如果我是制造商，在我的个人不良事件报告中我必须提交什么信息？

OBJECTIVE: To discuss the concepts and methods of medical device adverse event monitoring and risk man-agernent .

目的：初步探讨医疗器械不良事件监测和风险管理的概念和方法。

OBJECTIVE: To discuss the concepts and methods of medical device adverse event monitoring and risk man - agernent.

目的: 初步探讨医疗器械不良事件监测和风险管理的概念和方法.

The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports.

FDA已进行了一项新的分析研究现有的文献和上市后不良事件的报告。

The main driver of this adverse event rate in both arms of the study was a need for transfusion with two or more units of blood, in 9% of the clip patients and in 53% of the surgery patients.

两组不良事件发生率的主要组成事件为需要输两个或以上单位的血液，其在夹合器组为9%，而在外科治疗组为53%。