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 0.34% 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 0.34% 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 7,293 (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.

7,449
Total Reports
25
Event-type Death
131
Injury Reports
20
Device Types

Event Types

Malfunction 7,293 (97.9%)
Injury 131 (1.8%)
Death 25 (0.3%)

Patient Outcomes

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

7,253 (97.1%)
Required Intervention 86 (1.2%)
Life Threatening 41 (0.5%)
R 25 (0.3%)
Death 23 (0.3%)
L 15 (0.2%)
Hospitalization 12 (0.2%)
H 5 (0.1%)
Other 4 (0.1%)
D 3 (0.0%)

Devices (20)

Device Reports
Set, Administration, Intravascular 3,108
Stopcock, I.V. Set 2,313
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System 1,244
Transducer, Blood-Pressure, Extravascular 636
Catheter, Continuous Flush 47
Catheter, Intravascular, Diagnostic 35
Syringe, Piston 15
Set, I.V. Fluid Transfer 12
Pump, Infusion 10
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
Tubes, Gastrointestinal (And Accessories) 2
Catheter, Irrigation 1
Computer, Diagnostic, Pre-Programmed, Single-Function 1
Container, I.V. 1
Infusor, Pressure, For I.V. Bags 1
Probe, Thermodilution 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: 206

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