UNOMEDICAL A/S

Manufacturer adverse-event records for UNOMEDICAL A/S 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 · 2003–2026 · heavy-book · typical Death-code · balanced

Volume signature

UNOMEDICAL A/S sits in the heavy MAUDE book

UNOMEDICAL A/S accounts for 39,766 FDA MAUDE reports (#89 of 443, heavy-book tercile). Death-coded event_type share is 0.25% (typical); Injury share 11.6% (balanced).

What the volume reading shows for UNOMEDICAL A/S

The standout signal for UNOMEDICAL A/S is filing volume: 39,766 adverse-event reports in FDA MAUDE (#89 of 443, heavy-book). Death-coded event_type share sits at 0.25% (typical).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair UNOMEDICAL A/S with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 7 device types, led in this extract by Malfunction at 35,067 (88.2% of event_type total). Peak single-year volume reaches 34,255 reports across 22 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

39,766
Total Reports
101
Event-type Death
4,598
Injury Reports
7
Device Types

Event Types

Malfunction 35,067 (88.2%)
Injury 4,598 (11.6%)
Death 101 (0.3%)

Patient Outcomes

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

35,503 (83.6%)
Required Intervention 2,056 (4.8%)
Hospitalization 1,685 (4.0%)
H 1,212 (2.9%)
R 1,195 (2.8%)
Life Threatening 222 (0.5%)
L 200 (0.5%)
Other 116 (0.3%)
Death 114 (0.3%)
O 60 (0.1%)
Disability 33 (0.1%)
Congenital Anomaly 23 (0.1%)
S 22 (0.1%)
D 3 (0.0%)
C 2 (0.0%)

Yearly Trend

03
2003: 1
04
2004: 1
05
2005: 2
08
2008: 1
09
2009: 49
10
2010: 12
11
2011: 8
12
2012: 5
13
2013: 44
14
2014: 35
15
2015: 27
16
2016: 23
17
2017: 36
18
2018: 33
19
2019: 11
20
2020: 2
21
2021: 5
22
2022: 10
23
2023: 7
24
2024: 34,255
25
2025: 4,697
26
2026: 502