BAXTER HEALTHCARE - SWINFORD

FDA MAUDE device safety record · 2009–2019

What the Data Shows About BAXTER HEALTHCARE - SWINFORD

BAXTER HEALTHCARE - SWINFORD is associated with 4,400 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2009 through 2019. Of the total, 85 are coded as death reports and 2,116 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 4 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for BAXTER HEALTHCARE - SWINFORD 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 2,193 reports (49.8% of total). Patient-outcome categorizations are reported across 8 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 11 years of MAUDE data, with the peak single-year volume reaching 1,819 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.

4,400
Total Reports
85
Death Reports
2,116
Injury Reports
4
Device Types

Event Types

Malfunction 2,193 (49.8%)
Injury 2,116 (48.1%)
Death 85 (1.9%)
6 (0.1%)

Patient Outcomes

2,201 (41.2%)
Hospitalization 1,291 (24.2%)
R 858 (16.1%)
Required Intervention 535 (10.0%)
Other 282 (5.3%)
Death 91 (1.7%)
H 63 (1.2%)
O 15 (0.3%)

Yearly Trend

09
2009: 10
10
2010: 181
11
2011: 469
12
2012: 426
13
2013: 376
14
2014: 1,819
15
2015: 558
16
2016: 335
17
2017: 136
18
2018: 45
19
2019: 45

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.