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๐Ÿ“Š Group & Analyze - Statistics Feature

Overview

The Statistics feature transforms raw satefy database search results into clear, clustered insights. Instead of manually counting or exporting data, you can instantly explore tables that highlight key patterns across devices, manufacturers, and incident types.

This feature helps you:

  • ๐Ÿ“ˆ Easily manage high result volumes in FDA MAUDE
  • ๐Ÿ“Š Spot trends at a glance โ€“ identify recurring issues or risk patterns.

  • โฑ๏ธ Bulk Evaluate โ€“ no more tedious spreadsheet work.

  • โœ… Strengthen compliance โ€“ use evidence-based tables to support audits and risk management.

The Statistics is currently only available for MAUDE and BFARM reports. All other data sources are not yet included into the statistics data.

 

โ”How to Use

  • Run your safety database search as usual (You need some Bfarm or FDA Maude results).

  • Click on the โ€œStatisticsโ€ tab in your results view.

  • Group by a chosen category

  • Review the interactive table indicating the number of results and percentage of each subcategory

  • Drill into one category with the Add Filter button on the right side of a line. 

  • Bulk evaluate an entire group with the Paintbrush button on the right side of a line.
  • Download the Statistic view by clicking on Export<Statistics

Statistics

๐Ÿ” Insightful Example You Can Try

Group by Event Type to see which categories occur most often.

  • ๐Ÿ“Š For some devices, Injuries are reported more frequently.

  • โš™๏ธ For others, Malfunctions tend to dominate.

  • ๐Ÿ‘๏ธ Easily spot if Death events were reported for your type of device

Drill deeper:

  • On Death, Injury or Malfunction, click the connecting dots button on the right and select โ€œPatient Problem.โ€

  • You now get insights of all the adverse effects reported on patients for the type of Event you selected.

Take action:

  • ๐Ÿ“ฅ Export the statistical view to include these insights in your PMS report.