FRESENIUS VIAL S.A.S.

Manufacturer adverse-event records for FRESENIUS VIAL S.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 · 2017–2026 · thin-book · typical Death-code · injury-light

Volume signature

FRESENIUS VIAL S.A.S. is a thinner MAUDE footprint

FRESENIUS VIAL S.A.S. accounts for 4,078 FDA MAUDE reports (#412 of 434, thin-book tercile). Death-coded event_type share is 0.69% (typical); Injury share 2.4% (injury-light).

What the volume reading shows for FRESENIUS VIAL S.A.S.

The standout signal for FRESENIUS VIAL S.A.S. is filing volume: 4,078 adverse-event reports in FDA MAUDE (#412 of 434, thin-book). Death-coded event_type share sits at 0.69% (typical).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 1 device type, led in this extract by Malfunction at 3,953 (96.9% of event_type total). Peak single-year volume reaches 829 reports across 10 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,078
Total Reports
28
Event-type Death
97
Injury Reports
1
Device Types

Event Types

Malfunction 3,953 (96.9%)
Injury 97 (2.4%)
Death 28 (0.7%)

Patient Outcomes

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

3,169 (77.2%)
Other 806 (19.6%)
Required Intervention 36 (0.9%)
Death 26 (0.6%)
O 18 (0.4%)
Congenital Anomaly 14 (0.3%)
Life Threatening 14 (0.3%)
R 10 (0.2%)
L 5 (0.1%)
D 3 (0.1%)
Disability 3 (0.1%)
Hospitalization 3 (0.1%)

Devices (1)

Device Reports
Pump, Infusion 4,078

Yearly Trend

17
2017: 118
18
2018: 128
19
2019: 78
20
2020: 233
21
2021: 401
22
2022: 534
23
2023: 796
24
2024: 689
25
2025: 829
26
2026: 272