BAYER HEALTHCARE, LLC

Manufacturer adverse-event records for BAYER HEALTHCARE, LLC come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2003–2026 · thin-book · typical Death-code · balanced

Volume signature

BAYER HEALTHCARE, LLC is a thinner MAUDE footprint

BAYER HEALTHCARE, LLC accounts for 5,845 FDA MAUDE reports (#331 of 443, thin-book tercile). Death-coded event_type share is 0.09% (typical); Injury share 14.5% (balanced).

What the volume reading shows for BAYER HEALTHCARE, LLC

The standout signal for BAYER HEALTHCARE, LLC is filing volume: 5,845 adverse-event reports in FDA MAUDE (#331 of 443, thin-book). Death-coded event_type share sits at 0.09% (typical).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 14 device types, led in this extract by Malfunction at 4,963 (84.9% of event_type total). Peak single-year volume reaches 1,221 reports across 23 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,845
Total Reports
5
Event-type Death
845
Injury Reports
14
Device Types

Event Types

Malfunction 4,963 (84.9%)
Injury 845 (14.5%)
Other 19 (0.3%)
13 (0.2%)
Death 5 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

5,148 (83.3%)
Hospitalization 326 (5.3%)
Required Intervention 217 (3.5%)
R 197 (3.2%)
Other 81 (1.3%)
S 69 (1.1%)
Disability 58 (0.9%)
O 42 (0.7%)
L 17 (0.3%)
Life Threatening 9 (0.1%)
H 7 (0.1%)
Death 6 (0.1%)

Yearly Trend

03
2003: 15
04
2004: 105
05
2005: 169
06
2006: 1,109
07
2007: 767
08
2008: 1,221
09
2009: 874
10
2010: 654
11
2011: 407
12
2012: 185
13
2013: 46
14
2014: 16
15
2015: 3
16
2016: 3
18
2018: 69
19
2019: 69
20
2020: 55
21
2021: 37
22
2022: 13
23
2023: 10
24
2024: 7
25
2025: 9
26
2026: 2