ETHICON INC.

FDA MAUDE device safety record · 1992–2026

What the Data Shows About ETHICON INC.

ETHICON INC. is associated with 132,457 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1992 through 2026. Of the total, 292 are coded as death reports and 71,939 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 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for ETHICON INC. 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 Injury at 71,939 reports (54.3% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 22,176 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.

132,457
Total Reports
292
Death Reports
71,939
Injury Reports
20
Device Types

Event Types

Injury 71,939 (54.3%)
Malfunction 60,173 (45.4%)
Death 292 (0.2%)
42 (0.0%)
Other 11 (0.0%)

Patient Outcomes

Required Intervention 66,227 (49.8%)
62,295 (46.8%)
Other 2,843 (2.1%)
R 700 (0.5%)
Hospitalization 473 (0.4%)
Death 321 (0.2%)
D 53 (0.0%)
O 42 (0.0%)
S 31 (0.0%)
Life Threatening 31 (0.0%)
H 23 (0.0%)
L 16 (0.0%)
Disability 12 (0.0%)
Congenital Anomaly 6 (0.0%)

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 3
95
1995: 6
96
1996: 17
97
1997: 134
98
1998: 159
99
1999: 3
00
2000: 2
01
2001: 2
02
2002: 3
03
2003: 5
04
2004: 2
05
2005: 5
06
2006: 5
07
2007: 2
08
2008: 5
09
2009: 1
10
2010: 5
11
2011: 137
12
2012: 412
13
2013: 22,176
14
2014: 3,786
15
2015: 5,087
16
2016: 4,406
17
2017: 3,162
18
2018: 7,701
19
2019: 11,640
20
2020: 9,635
21
2021: 12,453
22
2022: 10,520
23
2023: 10,233
24
2024: 13,974
25
2025: 14,667
26
2026: 2,107

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.