UNK

Manufacturer adverse-event records for UNK 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 · 1992–2026 · mid-book · elevated Death-code · injury-heavy

Death-code intensity

UNK carries an elevated Death-code share

Death-coded event_type rows are 350 of 11,987 (2.92% · elevated tercile among 443 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for UNK

The standout signal for UNK is Death-code intensity: 2.92% of 11,987 reports (elevated tercile), while absolute volume is mid-book.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for UNK. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Injury at 7,609 (63.5% of event_type total). Peak single-year volume reaches 819 reports across 34 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

11,987
Total Reports
350
Event-type Death
7,609
Injury Reports
20
Device Types

Event Types

Injury 7,609 (63.5%)
Malfunction 2,473 (20.6%)
Other 1,016 (8.5%)
539 (4.5%)
Death 350 (2.9%)

Patient Outcomes

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

3,447 (23.2%)
Other 3,188 (21.4%)
Required Intervention 2,344 (15.7%)
Hospitalization 1,599 (10.7%)
R 994 (6.7%)
S 854 (5.7%)
Disability 765 (5.1%)
O 523 (3.5%)
L 346 (2.3%)
Death 324 (2.2%)
Life Threatening 293 (2.0%)
H 152 (1.0%)
Congenital Anomaly 32 (0.2%)
D 28 (0.2%)

Yearly Trend

92
1992: 1
94
1994: 7
95
1995: 11
96
1996: 386
97
1997: 819
98
1998: 711
99
1999: 520
00
2000: 534
01
2001: 466
02
2002: 438
03
2003: 400
04
2004: 304
05
2005: 301
06
2006: 234
07
2007: 300
08
2008: 174
09
2009: 141
10
2010: 160
11
2011: 151
12
2012: 147
13
2013: 156
14
2014: 80
15
2015: 116
16
2016: 230
17
2017: 459
18
2018: 593
19
2019: 616
20
2020: 493
21
2021: 723
22
2022: 503
23
2023: 630
24
2024: 536
25
2025: 467
26
2026: 180