COVIDIEN (IRVINE)

Manufacturer adverse-event records for COVIDIEN 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 · 2013–2019 · thin-book · elevated Death-code · balanced

Volume signature

COVIDIEN is a thinner MAUDE footprint

COVIDIEN (IRVINE) accounts for 3,679 FDA MAUDE reports (#430 of 443, thin-book tercile). Death-coded event_type share is 7.20% (elevated); Injury share 44.9% (balanced).

What the volume reading shows for COVIDIEN (IRVINE)

The standout signal for COVIDIEN (IRVINE) is filing volume: 3,679 adverse-event reports in FDA MAUDE (#430 of 443, thin-book). Death-coded event_type share sits at 7.20% (elevated).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 13 device types, led in this extract by Malfunction at 1,761 (47.9% of event_type total). Peak single-year volume reaches 1,165 reports across 7 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

3,679
Total Reports
265
Event-type Death
1,653
Injury Reports
13
Device Types

Event Types

Malfunction 1,761 (47.9%)
Injury 1,653 (44.9%)
Death 265 (7.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,656 (41.2%)
Required Intervention 811 (20.2%)
Other 571 (14.2%)
Disability 292 (7.3%)
Death 264 (6.6%)
S 171 (4.3%)
R 137 (3.4%)
Hospitalization 74 (1.8%)
O 29 (0.7%)
Life Threatening 11 (0.3%)
H 3 (0.1%)
L 1 (0.0%)

Yearly Trend

13
2013: 4
14
2014: 34
15
2015: 1,049
16
2016: 771
17
2017: 1,165
18
2018: 582
19
2019: 74