COOK IRELAND LTD

Manufacturer adverse-event records for COOK IRELAND LTD 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 · mid-book · typical Death-code · balanced

Injury-mix signature

COOK IRELAND LTD keeps a balanced Injury share

Injury-coded event_type share is 37.2% (balanced tercile) beside 0.27% Death-coded (typical). Volume band: mid.

What the Injury-mix reading shows for COOK IRELAND LTD

The standout signal for COOK IRELAND LTD is Injury-mix: 37.2% Injury-coded (balanced) beside 0.27% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for COOK IRELAND LTD. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Malfunction at 5,576 (62.5% of event_type total). Peak single-year volume reaches 1,040 reports across 20 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

8,918
Total Reports
24
Event-type Death
3,314
Injury Reports
20
Device Types

Event Types

Malfunction 5,576 (62.5%)
Injury 3,314 (37.2%)
Death 24 (0.3%)
4 (0.0%)

Patient Outcomes

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

5,635 (61.9%)
Required Intervention 2,941 (32.3%)
Hospitalization 197 (2.2%)
R 147 (1.6%)
Life Threatening 62 (0.7%)
Death 34 (0.4%)
Other 26 (0.3%)
S 18 (0.2%)
L 16 (0.2%)
Disability 16 (0.2%)
H 12 (0.1%)
O 5 (0.1%)
D 1 (0.0%)

Yearly Trend

06
2006: 1
08
2008: 4
09
2009: 12
10
2010: 23
11
2011: 27
12
2012: 75
13
2013: 145
14
2014: 331
15
2015: 303
16
2016: 397
17
2017: 623
18
2018: 597
19
2019: 824
20
2020: 1,040
21
2021: 958
22
2022: 969
23
2023: 994
24
2024: 891
25
2025: 638
26
2026: 66