BAYER PHARMA AG

Manufacturer adverse-event records for BAYER PHARMA AG 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 · 2009–2026 · heavy-book · typical Death-code · injury-heavy

Injury-mix signature

BAYER PHARMA AG leans injury-heavy in event_type mix

Injury-coded event_type share is 98.3% (injury-heavy tercile) beside 0.16% Death-coded (typical). Volume band: heavy.

What the Injury-mix reading shows for BAYER PHARMA AG

The standout signal for BAYER PHARMA AG is Injury-mix: 98.3% Injury-coded (injury-heavy) beside 0.16% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair BAYER PHARMA AG with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 2 device types, led in this extract by Injury at 62,136 (98.3% of event_type total). Peak single-year volume reaches 16,047 reports across 18 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

63,206
Total Reports
101
Event-type Death
62,136
Injury Reports
2
Device Types

Event Types

Injury 62,136 (98.3%)
Malfunction 796 (1.3%)
Other 116 (0.2%)
Death 101 (0.2%)
57 (0.1%)

Patient Outcomes

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

Other 53,169 (44.9%)
R 50,805 (42.9%)
Required Intervention 7,347 (6.2%)
O 3,463 (2.9%)
Hospitalization 1,900 (1.6%)
S 716 (0.6%)
480 (0.4%)
H 178 (0.2%)
Disability 149 (0.1%)
Death 73 (0.1%)
L 63 (0.1%)
Life Threatening 50 (0.0%)
Congenital Anomaly 18 (0.0%)
D 8 (0.0%)

Yearly Trend

09
2009: 79
10
2010: 65
11
2011: 58
12
2012: 59
13
2013: 65
14
2014: 535
15
2015: 1,959
16
2016: 2,383
17
2017: 11,215
18
2018: 5,390
19
2019: 14,873
20
2020: 16,047
21
2021: 3,659
22
2022: 1,599
23
2023: 3,606
24
2024: 817
25
2025: 720
26
2026: 77