COOK INC

Manufacturer adverse-event records for COOK INC 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 · 1995–2026 · heavy-book · elevated Death-code · balanced

Death-code intensity

COOK INC carries an elevated Death-code share

Death-coded event_type rows are 314 of 27,151 (1.16% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for COOK INC

The standout signal for COOK INC is Death-code intensity: 1.16% of 27,151 reports (elevated tercile), while absolute volume is heavy-book.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair COOK INC 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 20 device types, led in this extract by Malfunction at 16,122 (59.4% of event_type total). Peak single-year volume reaches 4,593 reports across 32 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

27,151
Total Reports
314
Event-type Death
10,696
Injury Reports
20
Device Types

Event Types

Malfunction 16,122 (59.4%)
Injury 10,696 (39.4%)
Death 314 (1.2%)
Other 15 (0.1%)
4 (0.0%)

Patient Outcomes

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

15,392 (52.3%)
Required Intervention 5,194 (17.7%)
Life Threatening 3,748 (12.7%)
Other 2,162 (7.3%)
O 1,455 (4.9%)
R 567 (1.9%)
Death 315 (1.1%)
Hospitalization 246 (0.8%)
L 137 (0.5%)
H 77 (0.3%)
S 55 (0.2%)
Disability 52 (0.2%)
D 20 (0.1%)

Yearly Trend

95
1995: 1
96
1996: 2
97
1997: 3
98
1998: 13
99
1999: 15
00
2000: 10
01
2001: 18
02
2002: 26
03
2003: 34
04
2004: 73
05
2005: 10
06
2006: 13
07
2007: 14
08
2008: 67
09
2009: 95
10
2010: 103
11
2011: 177
12
2012: 134
13
2013: 93
14
2014: 77
15
2015: 554
16
2016: 1,696
17
2017: 4,593
18
2018: 3,890
19
2019: 3,178
20
2020: 2,384
21
2021: 2,719
22
2022: 1,888
23
2023: 1,767
24
2024: 1,703
25
2025: 1,577
26
2026: 224