FRESENIUS MEDICAL CARE NORTH AMERICA

Manufacturer adverse-event records for FRESENIUS MEDICAL CARE NORTH AMERICA 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 · 1997–2026 · heavy-book · elevated Death-code · balanced

Death-code intensity

FRESENIUS MEDICAL CARE NORTH AMERICA carries an elevated Death-code share

Death-coded event_type rows are 24,684 of 37,655 (65.55% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for FRESENIUS MEDICAL CARE NORTH AMERICA

The standout signal for FRESENIUS MEDICAL CARE NORTH AMERICA is Death-code intensity: 65.55% of 37,655 reports (elevated tercile), while absolute volume is heavy-book.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair FRESENIUS MEDICAL CARE NORTH AMERICA 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 20 device types, led in this extract by Death at 24,684 (65.6% of event_type total). Peak single-year volume reaches 19,619 reports across 30 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

37,655
Total Reports
24,684
Event-type Death
8,790
Injury Reports
20
Device Types

Event Types

Death 24,684 (65.6%)
Injury 8,790 (23.3%)
Malfunction 4,032 (10.7%)
Other 101 (0.3%)
48 (0.1%)

Patient Outcomes

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

Death 24,560 (36.1%)
L 11,939 (17.5%)
R 7,763 (11.4%)
Hospitalization 6,599 (9.7%)
O 5,193 (7.6%)
S 4,950 (7.3%)
4,295 (6.3%)
Required Intervention 1,068 (1.6%)
Life Threatening 728 (1.1%)
H 612 (0.9%)
Other 391 (0.6%)
D 11 (0.0%)
Congenital Anomaly 11 (0.0%)
Disability 5 (0.0%)

Yearly Trend

97
1997: 17
98
1998: 24
99
1999: 23
00
2000: 2
01
2001: 9
02
2002: 17
03
2003: 16
04
2004: 20
05
2005: 30
06
2006: 16
07
2007: 21
08
2008: 13
09
2009: 29
10
2010: 10
11
2011: 17
12
2012: 106
13
2013: 4,786
14
2014: 19,619
15
2015: 10,752
16
2016: 2,061
17
2017: 8
18
2018: 3
19
2019: 4
20
2020: 5
21
2021: 2
22
2022: 7
23
2023: 11
24
2024: 7
25
2025: 18
26
2026: 2