UNOMEDICAL DEVICES S.A DE C.V

Manufacturer adverse-event records for UNOMEDICAL DEVICES S.A DE C.V 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 · 2011–2026 · heavy-book · typical Death-code · balanced

Volume signature

UNOMEDICAL DEVICES S.A DE C.V sits in the heavy MAUDE book

UNOMEDICAL DEVICES S.A DE C.V accounts for 47,973 FDA MAUDE reports (#80 of 434, heavy-book tercile). Death-coded event_type share is 0.58% (typical); Injury share 43.6% (balanced).

What the volume reading shows for UNOMEDICAL DEVICES S.A DE C.V

The standout signal for UNOMEDICAL DEVICES S.A DE C.V is filing volume: 47,973 adverse-event reports in FDA MAUDE (#80 of 434, heavy-book). Death-coded event_type share sits at 0.58% (typical).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair UNOMEDICAL DEVICES S.A DE C.V 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 6 device types, led in this extract by Malfunction at 26,770 (55.8% of event_type total). Peak single-year volume reaches 47,966 reports across 4 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

47,973
Total Reports
277
Event-type Death
20,926
Injury Reports
6
Device Types

Event Types

Malfunction 26,770 (55.8%)
Injury 20,926 (43.6%)
Death 277 (0.6%)

Patient Outcomes

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

32,922 (99.1%)
Death 280 (0.8%)
Disability 3 (0.0%)
H 1 (0.0%)
L 1 (0.0%)
Required Intervention 1 (0.0%)

Yearly Trend

11
2011: 3
23
2023: 1
24
2024: 3
26
2026: 47,966