scholarly journals Adverse event reporting tool to standardize the reporting and tracking of adverse events during procedural sedation: a consensus document from the World SIVA International Sedation Task Force

2012 ◽  
Vol 108 (1) ◽  
pp. 13-20 ◽  
Author(s):  
K.P. Mason ◽  
S.M. Green ◽  
Q. Piacevoli
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Task Force ◽  
Adverse Event Reporting ◽  
Procedural Sedation ◽  
Event Reporting ◽  
Consensus Document ◽  
The World ◽  
Reporting Tool

Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011–July 2018

Vaccine ◽  
2019 ◽  
Vol 37 (44) ◽  
pp. 6760-6767 ◽  
Author(s):  
Michael M. McNeil ◽  
Iwona Paradowska-Stankiewicz ◽  
Elaine R. Miller ◽  
Paige L. Marquez ◽  
Srihari Seshadri ◽  
...  
Keyword(s):  
United States ◽  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adenovirus Type ◽  
Adverse Event Reporting ◽  
Event Reporting

Antidepressants-related cardiovascular adverse events using the adverse event reporting system

2018 ◽  
Vol 268 ◽  
pp. 441-446 ◽  
Author(s):  
Yoon Kyong Lee ◽  
Jung Su Shin ◽  
Youngwon Kim ◽  
Jae Hyun Kim ◽  
Yun-Kyoung Song ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting

scholarly journals An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error

2020 ◽  
Vol 9 (1) ◽  
pp. 130-134
Author(s):  
Benjamin M. Knisely ◽  
Camille Levine ◽  
Kush C. Kharod ◽  
Monifa Vaughn-Cooke
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Medical Device ◽  
Medical Devices ◽  
Product Life Cycle ◽  
Risk Mitigation ◽  
Adverse Event Reporting ◽  
Mitigation Strategies ◽  
Event Reporting ◽  
Device Use

Humans can contribute to error at all stages of the medical device product life-cycle. Use error associated with medical devices can result in catastrophic consequences for end users and inefficient use of healthcare system resources. Industry-wide statistics about medical device use error has the potential to aid in identifying opportunities for human factors intervention, however publicly available statistics are sparse. The Food and Drug Administration (FDA) requires medical device manufactures, importers, and device user facilities to track and report adverse events for post-market surveillance through medical device reports (MDRs). This data is available in an online database: Manufacturer and User Facility Experience (MAUDE). This study provides a comprehensive evaluation of use error adverse events in MAUDE (2010-2018) based on device class, device operator, and event outcome, to address the lack of industry-wide statistics on medical device use error. Results indicate that use error is significantly represented in adverse event reporting, constituting 28.1% of reports labeled with device problem codes. Events associated with patient device operators were predominately associated with diabetes-related medical devices, while provider operators were associated with a wider array of devices. Additionally, it was found that most use error reports were attributed to issues with device output; using the device in accordance with manufacturer expectations; and physically activating, positioning, or separating device components. This work demonstrates the viability of using MAUDE to attain industry wide statistics on medical device use error for later integration in industry-wide or device-specific risk mitigation strategies.

Policy, Practice and Education 2004: Adverse event reporting by nurses

2004 ◽  
Vol 1 (1) ◽  
pp. 2-2
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
Policy Practice

Hunt JM and Gjoka G. Nurse reporting of adverse events caused by medicines. Nursing Times 2003; 99(49): 24–25.

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