Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death.
Sign Up to like & getrecommendations! Published in 2021 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2021.3942
Abstract: Importance In the US, most postmarket medical device safety data are obtained through adverse event reports that are submitted to the US Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database.… read more here.
Keywords: event reports; death; adverse event; medical device ... See more keywords
0509 Adverse Event Reports for CPAP, HNS and Oral Devices: An FDA MAUDE Database Analysis
Sign Up to like & getrecommendations! Published in 2023 at "SLEEP"
DOI: 10.1093/sleep/zsad077.0509
Abstract: This investigation analyzes adverse event reports (AERs) from the FDA MAUDE database for Continuous Positive Airway Pressure (CPAP), Hypoglossal Nerve Stimulation (HNS) and Oral Appliance Therapy (OAT) devices. The FDA defines adverse events as undesirable… read more here.
Keywords: event reports; event; maude database; adverse event ... See more keywords
The Influence of the Rapid Increase in the Number of Adverse Event Reports for COVID-19 Vaccine on the Disproportionality Analysis Using JADER
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DOI: 10.21873/invivo.13085
Abstract: Abstract Background/Aim: The COVID-19 prophylactic vaccine for the prevention of coronavirus infection was approved in Japan on February 14, 2021. Adverse event reports for the vaccine were collected from the Japan Adverse Drug Event Relief… read more here.
Keywords: event reports; event; number; adverse event ... See more keywords
Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016
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DOI: 10.3389/fmed.2018.00167
Abstract: The objective of this study is to collate and analyse adverse event reports associated with the use of complementary health products (CHP) submitted to the Health Sciences Authority (HSA) of Singapore for the period 2010–2016… read more here.
Keywords: medicine; adverse event; event reports; 2010 2016 ... See more keywords