CPI - DEL CARIBE

Manufacturer adverse-event records for CPI - DEL CARIBE 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 · 2003–2023 · heavy-book · elevated Death-code · injury-heavy

Volume signature

CPI - DEL CARIBE sits in the heavy MAUDE book

CPI - DEL CARIBE accounts for 64,619 FDA MAUDE reports (#51 of 443, heavy-book tercile). Death-coded event_type share is 0.95% (elevated); Injury share 73.9% (injury-heavy).

What the volume reading shows for CPI - DEL CARIBE

The standout signal for CPI - DEL CARIBE is filing volume: 64,619 adverse-event reports in FDA MAUDE (#51 of 443, heavy-book). Death-coded event_type share sits at 0.95% (elevated).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair CPI - DEL CARIBE 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 12 device types, led in this extract by Injury at 47,768 (73.9% of event_type total). Peak single-year volume reaches 8,494 reports across 17 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

64,619
Total Reports
615
Event-type Death
47,768
Injury Reports
12
Device Types

Event Types

Injury 47,768 (73.9%)
Malfunction 16,224 (25.1%)
Death 615 (1.0%)
6 (0.0%)
Other 6 (0.0%)

Patient Outcomes

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

R 33,708 (26.2%)
Hospitalization 31,486 (24.5%)
L 30,862 (24.0%)
17,992 (14.0%)
Required Intervention 6,854 (5.3%)
Life Threatening 3,429 (2.7%)
Other 2,938 (2.3%)
Death 639 (0.5%)
O 398 (0.3%)
H 280 (0.2%)
S 87 (0.1%)
Congenital Anomaly 29 (0.0%)
Disability 17 (0.0%)

Yearly Trend

03
2003: 7
04
2004: 8
05
2005: 8
06
2006: 30
07
2007: 56
08
2008: 86
09
2009: 5,694
10
2010: 7,132
11
2011: 8,038
12
2012: 5,750
13
2013: 5,312
14
2014: 5,202
15
2015: 4,766
16
2016: 6,172
17
2017: 7,845
18
2018: 8,494
23
2023: 19