AV-TEMECULA-CT

Manufacturer adverse-event records for AV-TEMECULA-CT 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 · 2008–2019 · heavy-book · elevated Death-code · injury-heavy

Volume signature

AV-TEMECULA-CT sits in the heavy MAUDE book

AV-TEMECULA-CT accounts for 77,603 FDA MAUDE reports (#42 of 443, heavy-book tercile). Death-coded event_type share is 3.22% (elevated); Injury share 62.8% (injury-heavy).

What the volume reading shows for AV-TEMECULA-CT

The standout signal for AV-TEMECULA-CT is filing volume: 77,603 adverse-event reports in FDA MAUDE (#42 of 443, heavy-book). Death-coded event_type share sits at 3.22% (elevated).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair AV-TEMECULA-CT 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 Injury at 48,755 (62.8% of event_type total). Peak single-year volume reaches 10,159 reports across 12 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

77,603
Total Reports
2,495
Event-type Death
48,755
Injury Reports
20
Device Types

Event Types

Injury 48,755 (62.8%)
Malfunction 26,353 (34.0%)
Death 2,495 (3.2%)

Patient Outcomes

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

Required Intervention 38,607 (44.0%)
26,223 (29.9%)
Hospitalization 7,708 (8.8%)
R 7,220 (8.2%)
S 2,529 (2.9%)
Death 2,518 (2.9%)
Other 2,228 (2.5%)
Disability 253 (0.3%)
O 174 (0.2%)
L 101 (0.1%)
H 72 (0.1%)
Life Threatening 57 (0.1%)
Congenital Anomaly 9 (0.0%)
D 3 (0.0%)

Yearly Trend

08
2008: 2
09
2009: 4
10
2010: 210
11
2011: 8,844
12
2012: 8,279
13
2013: 8,408
14
2014: 8,575
15
2015: 8,029
16
2016: 9,425
17
2017: 10,159
18
2018: 10,087
19
2019: 5,581