COLOPLAST A/S

Manufacturer adverse-event records for COLOPLAST A/S 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 · 1998–2026 · mid-book · typical Death-code · injury-heavy

Injury-mix signature

COLOPLAST A/S leans injury-heavy in event_type mix

Injury-coded event_type share is 79.9% (injury-heavy tercile) beside 0.09% Death-coded (typical). Volume band: mid.

What the Injury-mix reading shows for COLOPLAST A/S

The standout signal for COLOPLAST A/S is Injury-mix: 79.9% Injury-coded (injury-heavy) beside 0.09% Death-coded, on a mid-book footprint.

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

Reports span 20 device types, led in this extract by Injury at 13,839 (79.9% of event_type total). Peak single-year volume reaches 2,552 reports across 23 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

17,327
Total Reports
15
Event-type Death
13,839
Injury Reports
20
Device Types

Event Types

Injury 13,839 (79.9%)
Malfunction 3,464 (20.0%)
Death 15 (0.1%)
5 (0.0%)
Other 4 (0.0%)

Patient Outcomes

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

Required Intervention 7,504 (40.4%)
Other 4,976 (26.8%)
3,551 (19.1%)
Hospitalization 1,073 (5.8%)
R 988 (5.3%)
O 263 (1.4%)
H 74 (0.4%)
Life Threatening 53 (0.3%)
L 29 (0.2%)
S 23 (0.1%)
Death 16 (0.1%)
Disability 12 (0.1%)
Congenital Anomaly 4 (0.0%)
D 1 (0.0%)

Yearly Trend

98
1998: 2
01
2001: 1
03
2003: 2
05
2005: 1
08
2008: 7
09
2009: 3
10
2010: 80
11
2011: 123
12
2012: 196
13
2013: 626
14
2014: 482
15
2015: 173
16
2016: 494
17
2017: 712
18
2018: 971
19
2019: 1,179
20
2020: 1,300
21
2021: 1,925
22
2022: 1,568
23
2023: 2,004
24
2024: 2,519
25
2025: 2,552
26
2026: 407