PlainHospital

ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.

Manufacturer adverse-event records for ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 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 · 2017–2026 · mid-book · typical Death-code · injury-light

Injury-mix signature

ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. is lighter on Injury codes

Injury-coded event_type share is 1.8% (injury-light tercile) beside 0.32% Death-coded (typical). Volume band: mid.

What the Injury-mix reading shows for ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.

The standout signal for ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. is Injury-mix: 1.8% Injury-coded (injury-light) beside 0.32% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Malfunction at 7,993 (97.9% of event_type total). Peak single-year volume reaches 2,324 reports across 10 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

8,163
Total Reports
26
Event-type Death
144
Injury Reports
20
Device Types

Event Types

Malfunction 7,993 (97.9%)
Injury 144 (1.8%)
Death 26 (0.3%)

Patient Outcomes

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

7,841 (97.2%)
Required Intervention 92 (1.1%)
Life Threatening 42 (0.5%)
R 27 (0.3%)
Death 24 (0.3%)
L 15 (0.2%)
Hospitalization 14 (0.2%)
H 5 (0.1%)
Other 5 (0.1%)
D 3 (0.0%)

Devices (20)

Device Reports
Set, Administration, Intravascular 3,431
Stopcock, I.V. Set 2,519
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System 1,386
Transducer, Blood-Pressure, Extravascular 666
Catheter, Continuous Flush 48
Catheter, Intravascular, Diagnostic 37
Syringe, Piston 17
Set, I.V. Fluid Transfer 12
Pump, Infusion 10
Tubes, Gastrointestinal (And Accessories) 7
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 6
Catheter, Oximeter, Fiber-Optic 4
Pump, Infusion, Pca 4
Blood Pressure Cuff 3
Needle, Hypodermic, Single Lumen 3
Probe, Thermodilution 2
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1
Catheter, Irrigation 1
Computer, Diagnostic, Pre-Programmed, Single-Function 1
Container, I.V. 1

Yearly Trend

17
2017: 2
18
2018: 176
19
2019: 431
20
2020: 545
21
2021: 287
22
2022: 342
23
2023: 1,212
24
2024: 1,924
25
2025: 2,324
26
2026: 920

Read our methodology - how this data is sourced, computed, and verified.