Device Events is a cloud-based software service that extracts, consolidates, and provides comprehensive information on the millions of FDA medical device adverse event reports (MDRs). You can access the system at your convenience once you have account login credentials.
The system provides you with fast and cost-effective access to the most up-to-date information available – so you can quickly identify problem devices, understand the history, quantity and severity of the related adverse events and make better, more informed decisions.
The Device Events system will improve the quality of your research while reducing the amount of time you spend on that research. The result is improved patient safety, better health outcomes, and reduced risk for healthcare organizations.
|Search||Search MDRs by Manufacturer, Device or any word or phrase (i.e. a side effect, critical event, symptom, etc.)|
|Comprehensive Filtering||Filter by date, record type, report type, report submitter, submitter occupation, company name, brand name, device name, model, catalog number, product code, device problem, country code, and more.|
|Search Metrics||Metrics on Search Results, e.g. MDR report types, (Death, Malfunction, Injury, Other), submitters, occupations, etc.|
|MDR Report Preview||Preview of 5 lines of the MDR surrounding the highlighted keywords|
|MDR Report Detail||View the full MDR report|
|Link to FDA Public MAUDE report-view||Access the FDA Public MAUDE report-view|
|Keyword Metrics & Highlighter||Define keywords (e.g. side effects, critical events, etc.) and see associated keyword metrics along with keywords highlighted in the exported Research report.|
|Research Report||Exportable comprehensive report (Excel or .csv format) of all search results and keyword metrics. Keywords are highlighted when report is exported to Excel.|
|Trend Charts||Users can view their search results in a trend chart.|
|Adverse Event Email Notifications||Users receive monthly email notifications on any new adverse event activity for medical devices of interest.|
CLICK HERE to view a demonstration of Device Events
Device Events can also provide Research reports to your specific requirements. Research reports on a medical device or device manufacturer are provided in Microsoft Excel and typically include:
- All FDA MDRs (FDA Medical Device Adverse Event Reports) with details
- Links to the FDA Public MAUDE reports
- Metrics on keywords, i.e. side effects, treatments, symptoms, etc.
- Highlighted keywords are provided in the individual MDR report details when exported to Excel
- A report in Excel or .CSV format
Contact us to learn more.