ANIMAS CORPORATION

Manufacturer adverse-event records for ANIMAS CORPORATION 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 · 2001–2023 · heavy-book · quiet Death-code · injury-light

Volume signature

ANIMAS CORPORATION sits in the heavy MAUDE book

ANIMAS CORPORATION accounts for 202,641 FDA MAUDE reports (#14 of 443, heavy-book tercile). Death-coded event_type share is 0.06% (quiet); Injury share 6.7% (injury-light).

What the volume reading shows for ANIMAS CORPORATION

The standout signal for ANIMAS CORPORATION is filing volume: 202,641 adverse-event reports in FDA MAUDE (#14 of 443, heavy-book). Death-coded event_type share sits at 0.06% (quiet).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ANIMAS CORPORATION 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 16 device types, led in this extract by Malfunction at 188,076 (92.8% of event_type total). Peak single-year volume reaches 46,541 reports across 19 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

202,641
Total Reports
124
Event-type Death
13,593
Injury Reports
16
Device Types

Event Types

Malfunction 188,076 (92.8%)
Injury 13,593 (6.7%)
846 (0.4%)
Death 124 (0.1%)
Other 2 (0.0%)

Patient Outcomes

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

189,703 (91.2%)
Life Threatening 8,925 (4.3%)
Hospitalization 3,376 (1.6%)
R 3,333 (1.6%)
L 2,037 (1.0%)
Required Intervention 480 (0.2%)
Death 127 (0.1%)
Other 22 (0.0%)
H 14 (0.0%)
O 9 (0.0%)
Disability 8 (0.0%)
S 4 (0.0%)

Yearly Trend

01
2001: 16
02
2002: 27
03
2003: 13
04
2004: 9
05
2005: 46
06
2006: 100
07
2007: 171
08
2008: 171
09
2009: 206
10
2010: 672
11
2011: 6,910
12
2012: 14,839
13
2013: 25,265
14
2014: 36,770
15
2015: 46,541
16
2016: 32,933
17
2017: 27,851
18
2018: 10,100
23
2023: 1