BAXTER HEALTHCARE - SINGAPORE

FDA MAUDE device safety record · 2008–2019

What the Data Shows About BAXTER HEALTHCARE - SINGAPORE

BAXTER HEALTHCARE - SINGAPORE is associated with 73,286 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2008 through 2019. Of the total, 485 are coded as death reports and 581 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 - SINGAPORE should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 72,135 reports (98.4% of total). Patient-outcome categorizations are reported across 11 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 37,295 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.

73,286
Total Reports
485
Death Reports
581
Injury Reports
12
Device Types

Event Types

Malfunction 72,135 (98.4%)
Injury 581 (0.8%)
Death 485 (0.7%)
84 (0.1%)
Other 1 (0.0%)

Patient Outcomes

72,228 (98.1%)
Death 487 (0.7%)
Hospitalization 298 (0.4%)
R 215 (0.3%)
Required Intervention 156 (0.2%)
Other 105 (0.1%)
H 85 (0.1%)
O 18 (0.0%)
Life Threatening 9 (0.0%)
Congenital Anomaly 2 (0.0%)
Disability 1 (0.0%)

Yearly Trend

08
2008: 5
09
2009: 457
10
2010: 3,797
11
2011: 37,295
12
2012: 11,410
13
2013: 4,655
14
2014: 6,284
15
2015: 5,938
16
2016: 1,772
17
2017: 1,010
18
2018: 449
19
2019: 214

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.