ALLERGAN

FDA MAUDE device safety record · 1995–2026

What the Data Shows About ALLERGAN

ALLERGAN is associated with 9,017 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1995 through 2026. Of the total, 91 are coded as death reports and 5,807 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 ALLERGAN 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 5,807 reports (64.4% 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 31 years of MAUDE data, with the peak single-year volume reaching 1,362 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.

9,017
Total Reports
91
Death Reports
5,807
Injury Reports
20
Device Types

Event Types

Injury 5,807 (64.4%)
Malfunction 3,070 (34.0%)
Death 91 (1.0%)
30 (0.3%)
Other 19 (0.2%)

Patient Outcomes

Required Intervention 3,988 (37.2%)
3,101 (28.9%)
Hospitalization 769 (7.2%)
R 736 (6.9%)
S 522 (4.9%)
Other 507 (4.7%)
Disability 425 (4.0%)
O 204 (1.9%)
L 164 (1.5%)
Death 93 (0.9%)
Life Threatening 88 (0.8%)
H 84 (0.8%)
Congenital Anomaly 44 (0.4%)
C 1 (0.0%)

Yearly Trend

95
1995: 1
96
1996: 6
97
1997: 45
98
1998: 23
99
1999: 43
00
2000: 60
01
2001: 49
02
2002: 15
03
2003: 4
04
2004: 1
05
2005: 3
07
2007: 1
08
2008: 18
09
2009: 437
10
2010: 1,113
11
2011: 1,156
12
2012: 1,362
13
2013: 1,131
14
2014: 1,278
15
2015: 757
16
2016: 66
17
2017: 77
18
2018: 98
19
2019: 550
20
2020: 197
21
2021: 126
22
2022: 117
23
2023: 102
24
2024: 110
25
2025: 64
26
2026: 7

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.