BAXTER HEALTHCARE - LARGO

FDA MAUDE device safety record · 2008–2019

What the Data Shows About BAXTER HEALTHCARE - LARGO

BAXTER HEALTHCARE - LARGO is associated with 38,514 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2008 through 2019. Of the total, 960 are coded as death reports and 862 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 12 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for BAXTER HEALTHCARE - LARGO should be reviewed at the device-family level rather than company-wide. Across those devices, 4 distinct event types appear in the record, led by Malfunction at 36,663 reports (95.2% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 12 years of MAUDE data, with the peak single-year volume reaching 9,957 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.

38,514
Total Reports
960
Death Reports
862
Injury Reports
12
Device Types

Event Types

Malfunction 36,663 (95.2%)
Death 960 (2.5%)
Injury 862 (2.2%)
29 (0.1%)

Patient Outcomes

36,695 (94.0%)
Death 967 (2.5%)
Hospitalization 468 (1.2%)
R 305 (0.8%)
Required Intervention 213 (0.5%)
H 175 (0.4%)
Other 167 (0.4%)
O 31 (0.1%)
L 3 (0.0%)
Life Threatening 3 (0.0%)
D 1 (0.0%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

08
2008: 14
09
2009: 133
10
2010: 1,645
11
2011: 2,953
12
2012: 9,957
13
2013: 8,142
14
2014: 8,144
15
2015: 7,089
16
2016: 319
17
2017: 81
18
2018: 30
19
2019: 7

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.