NORTH HAVEN - USS

Manufacturer adverse-event records for NORTH HAVEN - USS 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 · 2000–2010 · thin-book · elevated Death-code · injury-heavy

Volume signature

NORTH HAVEN - USS is a thinner MAUDE footprint

NORTH HAVEN - USS accounts for 4,065 FDA MAUDE reports (#405 of 443, thin-book tercile). Death-coded event_type share is 1.38% (elevated); Injury share 75.4% (injury-heavy).

What the volume reading shows for NORTH HAVEN - USS

The standout signal for NORTH HAVEN - USS is filing volume: 4,065 adverse-event reports in FDA MAUDE (#405 of 443, thin-book). Death-coded event_type share sits at 1.38% (elevated).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 20 device types, led in this extract by Injury at 3,067 (75.4% of event_type total). Peak single-year volume reaches 815 reports across 11 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,065
Total Reports
56
Event-type Death
3,067
Injury Reports
20
Device Types

Event Types

Injury 3,067 (75.4%)
Malfunction 920 (22.6%)
Death 56 (1.4%)
20 (0.5%)
Other 2 (0.0%)

Patient Outcomes

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

Required Intervention 1,728 (37.4%)
1,043 (22.6%)
Other 584 (12.6%)
Hospitalization 474 (10.3%)
R 473 (10.2%)
Disability 171 (3.7%)
Death 58 (1.3%)
S 43 (0.9%)
O 35 (0.8%)
Life Threatening 9 (0.2%)
L 4 (0.1%)
H 1 (0.0%)

Yearly Trend

00
2000: 5
01
2001: 84
02
2002: 227
03
2003: 290
04
2004: 341
05
2005: 298
06
2006: 421
07
2007: 651
08
2008: 815
09
2009: 803
10
2010: 130