BAXTER HLTHCARE CORP

FDA MAUDE device safety record · 2012–2019

What the Data Shows About BAXTER HLTHCARE CORP

BAXTER HLTHCARE CORP is associated with 6,772 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2012 through 2019. Of the total, 0 are coded as death reports and 1 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 2 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for BAXTER HLTHCARE CORP should be reviewed at the device-family level rather than company-wide. Across those devices, 2 distinct event types appear in the record, led by Malfunction at 6,771 reports (100.0% of total). Patient-outcome categorizations are reported across 1 distinct outcome, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 5 years of MAUDE data, with the peak single-year volume reaching 6,322 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.

6,772
Total Reports
0
Death Reports
1
Injury Reports
2
Device Types

Event Types

Malfunction 6,771 (100.0%)
Injury 1 (0.0%)

Patient Outcomes

6,772 (100.0%)

Yearly Trend

12
2012: 3
13
2013: 23
14
2014: 6,322
15
2015: 423
19
2019: 1

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.