FRESENIUS VIAL S.A.S.

FDA MAUDE device safety record · 2017–2026

What the Data Shows About FRESENIUS VIAL S.A.S.

FRESENIUS VIAL S.A.S. is associated with 3,866 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2017 through 2026. Of the total, 24 are coded as death reports and 79 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 1 distinct device type attributed to this manufacturer in MAUDE, which means any safety read for FRESENIUS VIAL S.A.S. should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Malfunction at 3,763 reports (97.3% of total). Patient-outcome categorizations are reported across 12 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 10 years of MAUDE data, with the peak single-year volume reaching 829 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

3,866
Total Reports
24
Death Reports
79
Injury Reports
1
Device Types

Event Types

Malfunction 3,763 (97.3%)
Injury 79 (2.0%)
Death 24 (0.6%)

Patient Outcomes

2,981 (76.7%)
Other 797 (20.5%)
Required Intervention 32 (0.8%)
Death 22 (0.6%)
Congenital Anomaly 14 (0.4%)
O 11 (0.3%)
Life Threatening 9 (0.2%)
R 8 (0.2%)
D 3 (0.1%)
Disability 3 (0.1%)
Hospitalization 3 (0.1%)
L 2 (0.1%)

Devices (1)

Device Reports
Pump, Infusion 3,866

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: 60

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.