NIPRO DIAGNOSTICS, INC.

Manufacturer adverse-event records for NIPRO DIAGNOSTICS, INC. 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 · 2010–2017 · thin-book · typical Death-code · injury-light

Injury-mix signature

NIPRO DIAGNOSTICS, INC. is lighter on Injury codes

Injury-coded event_type share is 0.1% (injury-light tercile) beside 0.20% Death-coded (typical). Volume band: thin.

What the Injury-mix reading shows for NIPRO DIAGNOSTICS, INC.

The standout signal for NIPRO DIAGNOSTICS, INC. is Injury-mix: 0.1% Injury-coded (injury-light) beside 0.20% Death-coded, on a thin-book footprint.

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 6 device types, led in this extract by Malfunction at 3,955 (99.4% of event_type total). Peak single-year volume reaches 2,430 reports across 8 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

3,979
Total Reports
8
Event-type Death
3
Injury Reports
6
Device Types

Event Types

Malfunction 3,955 (99.4%)
Other 10 (0.3%)
Death 8 (0.2%)
3 (0.1%)
Injury 3 (0.1%)

Patient Outcomes

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

3,794 (95.4%)
Hospitalization 156 (3.9%)
Other 15 (0.4%)
Death 8 (0.2%)
Required Intervention 4 (0.1%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Yearly Trend

10
2010: 35
11
2011: 60
12
2012: 36
13
2013: 294
14
2014: 602
15
2015: 2,430
16
2016: 511
17
2017: 11