OpenFDA Adverse Event Intel
Medical Device Analytics Dashboard
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Analyzing Data
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Total Records
Avg Lifespan
Recalls
Removal Rate
Avg Delay
Past Expiry
Follow-up Rate
Event Severity
Distribution of adverse event severity classifications
Age Distribution
Patient age group breakdown across reported events
Reporting Delay
Time between event occurrence and FDA report submission
Device Lifespan at Failure
How long devices were in service before the adverse event
Device Expiry Proximity
Relationship between device expiry status and event severity
Day of Week Pattern
Temporal distribution of events across weekdays
Top Product Problems
Most frequently reported device-related issues
Patient Problems
Most frequently reported patient outcomes and symptoms
Problem → Patient Outcome
Top co-occurring product problem and patient outcome pairs
Failure Mode Treemap
Hierarchical view of failure modes grouped by event severity
Severity vs Sex
Event severity breakdown by patient sex
Source vs Severity
Reporting source categories by event severity
Reporter vs Severity
Event severity by reporter occupation type
Device Operator vs Severity
Event severity by the person operating the device
Health Professional Involved
Whether a health professional was involved in the event
Event Location
Where the adverse event occurred
Product Problem Identified
Whether a product problem was flagged
Report Type
Submission chain length and follow-up pattern
Device Class
FDA device classification level
Device Availability
Post-event device return status
Reporting Delay by Severity
Mean vs median reporting lag grouped by event outcome
Follow-up Reports by Severity
Supplemental report submission rate across severity levels
Report Source Pathway
How reports entered the FDA system
Initially Reported to FDA
Whether the event was initially reported directly to the FDA
Geographic Distribution
Countries where adverse events were reported
Country vs Severity
Event severity breakdown by reporting country
Manufacturer Evaluation
Whether the manufacturer evaluated the reported device
Evaluation Status vs Severity
How evaluation status correlates with event severity
Remedial Action vs Severity
Corrective actions taken and their severity association
Reuse Safety
Device reuse and reprocessing classification
Previous Use
Whether the device had been used before the event
Top Manufacturers
Top Device Names
Top Brand Names
Joint Distribution
Cluster Analysis
Fuzzy matching results grouping similar manufacturers, devices, and brands
Monthly Event Volume
Chronological trend of adverse event report submissions
Adverse Events by Severity
Monthly trends broken down by event severity classification
Year-over-Year Growth
Annual change in event volume — decrease indicates improving safety