منابع مشابه
Using Failure Modes, Mechanisms, and Effects Analysis in Medical Device Adverse Event Investigations
In the United States, when medical devices are associated with adverse events that result in death or serious injury, or have malfunctions that could lead to death/serious injury, these events must be reported to the Food and Drug Administration’s Center for Devices and Radiologic Health by device manufacturers and user facilities. However, the defects in the medical device evaluation process (...
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BACKGROUND Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. METHODS To analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of cardiovascular devices were retrieved. Two durations were calculated: (1) time from the date the A...
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The selective serotonin reuptake inhibitors have a very favorable safety profile. However, because of the wide use of this drug group, even low-frequency adverse effects become more prevalent. This article reviews 5 of these relatively infrequent adverse medical effects associated with the use of selective serotonin reuptake inhibitors: the syndrome of inappropriate antidiuretic hormone secreti...
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For over two decades, cannabis, commonly known as marijuana, has been the most widely used illicit drug by young people in high-income countries, and has recently become popular on a global scale. Epidemiological research during the past 10 years suggests that regular use of cannabis during adolescence and into adulthood can have adverse effects. Epidemiological, clinical, and laboratory studie...
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ژورنال
عنوان ژورنال: Journal of the Korean Medical Association
سال: 2019
ISSN: 1975-8456,2093-5951
DOI: 10.5124/jkma.2019.62.9.480