NIHON KOHDEN CORPORATION

Manufacturer adverse-event records for NIHON KOHDEN CORPORATION 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 · 2008–2026 · thin-book · elevated Death-code · injury-light

Injury-mix signature

NIHON KOHDEN CORPORATION is lighter on Injury codes

Injury-coded event_type share is 0.7% (injury-light tercile) beside 1.04% Death-coded (elevated). Volume band: thin.

What the Injury-mix reading shows for NIHON KOHDEN CORPORATION

The standout signal for NIHON KOHDEN CORPORATION is Injury-mix: 0.7% Injury-coded (injury-light) beside 1.04% 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 16 device types, led in this extract by Malfunction at 6,771 (98.2% of event_type total). Peak single-year volume reaches 1,633 reports across 14 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

6,898
Total Reports
72
Event-type Death
48
Injury Reports
16
Device Types

Event Types

Malfunction 6,771 (98.2%)
Death 72 (1.0%)
Injury 48 (0.7%)
Other 4 (0.1%)
3 (0.0%)

Patient Outcomes

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

6,652 (96.2%)
Other 84 (1.2%)
Death 78 (1.1%)
Required Intervention 23 (0.3%)
Life Threatening 21 (0.3%)
R 19 (0.3%)
Hospitalization 13 (0.2%)
Disability 11 (0.2%)
Congenital Anomaly 8 (0.1%)
O 2 (0.0%)
D 1 (0.0%)
S 1 (0.0%)

Yearly Trend

08
2008: 1
14
2014: 169
15
2015: 214
16
2016: 272
17
2017: 395
18
2018: 499
19
2019: 742
20
2020: 806
21
2021: 1,633
22
2022: 486
23
2023: 352
24
2024: 286
25
2025: 637
26
2026: 406