INSULET CORPORATION
Manufacturer adverse-event records for INSULET CORPORATION come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.
FDA MAUDE device safety record · 2006–2026 · heavy-book · typical Death-code · balanced
Volume signature
INSULET CORPORATION sits in the heavy MAUDE book
INSULET CORPORATION accounts for 315,926 FDA MAUDE reports (#11 of 434, heavy-book tercile). Death-coded event_type share is 0.10% (typical); Injury share 11.6% (balanced).
What the volume reading shows for INSULET CORPORATION
The standout signal for INSULET CORPORATION is filing volume: 315,926 adverse-event reports in FDA MAUDE (#11 of 434, heavy-book). Death-coded event_type share sits at 0.10% (typical).
As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair INSULET CORPORATION with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.
Reports span 14 device types, led in this extract by Malfunction at 278,365 (88.1% of event_type total). Peak single-year volume reaches 65,362 reports across 21 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Devices (14)
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.