PONCE - USS

Manufacturer adverse-event records for PONCE - 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

PONCE - USS is a thinner MAUDE footprint

PONCE - USS accounts for 4,250 FDA MAUDE reports (#397 of 443, thin-book tercile). Death-coded event_type share is 1.55% (elevated); Injury share 49.3% (injury-heavy).

What the volume reading shows for PONCE - USS

The standout signal for PONCE - USS is filing volume: 4,250 adverse-event reports in FDA MAUDE (#397 of 443, thin-book). Death-coded event_type share sits at 1.55% (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 2,096 (49.3% of event_type total). Peak single-year volume reaches 619 reports across 11 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,250
Total Reports
66
Event-type Death
2,096
Injury Reports
20
Device Types

Event Types

Injury 2,096 (49.3%)
Malfunction 1,948 (45.8%)
Other 135 (3.2%)
Death 66 (1.6%)
5 (0.1%)

Patient Outcomes

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

2,180 (48.1%)
Required Intervention 1,423 (31.4%)
Other 309 (6.8%)
R 234 (5.2%)
Hospitalization 232 (5.1%)
Death 63 (1.4%)
Life Threatening 28 (0.6%)
O 22 (0.5%)
S 14 (0.3%)
Disability 14 (0.3%)
L 12 (0.3%)
Congenital Anomaly 4 (0.1%)

Yearly Trend

00
2000: 2
01
2001: 74
02
2002: 234
03
2003: 261
04
2004: 601
05
2005: 531
06
2006: 482
07
2007: 562
08
2008: 619
09
2009: 617
10
2010: 267