US SURGICAL PUERTO RICO

Manufacturer adverse-event records for US SURGICAL PUERTO RICO 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 · 2017–2025 · heavy-book · typical Death-code · balanced

Volume signature

US SURGICAL PUERTO RICO sits in the heavy MAUDE book

US SURGICAL PUERTO RICO accounts for 43,673 FDA MAUDE reports (#82 of 443, heavy-book tercile). Death-coded event_type share is 0.36% (typical); Injury share 13.0% (balanced).

What the volume reading shows for US SURGICAL PUERTO RICO

The standout signal for US SURGICAL PUERTO RICO is filing volume: 43,673 adverse-event reports in FDA MAUDE (#82 of 443, heavy-book). Death-coded event_type share sits at 0.36% (typical).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair US SURGICAL PUERTO RICO 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 20 device types, led in this extract by Malfunction at 37,830 (86.6% of event_type total). Peak single-year volume reaches 6,422 reports across 9 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

43,673
Total Reports
157
Event-type Death
5,686
Injury Reports
20
Device Types

Event Types

Malfunction 37,830 (86.6%)
Injury 5,686 (13.0%)
Death 157 (0.4%)

Patient Outcomes

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

37,493 (82.3%)
Required Intervention 4,013 (8.8%)
R 1,249 (2.7%)
Other 1,103 (2.4%)
Hospitalization 821 (1.8%)
H 258 (0.6%)
O 240 (0.5%)
Death 118 (0.3%)
Life Threatening 78 (0.2%)
L 77 (0.2%)
D 39 (0.1%)
S 38 (0.1%)
Disability 14 (0.0%)
Congenital Anomaly 2 (0.0%)

Yearly Trend

17
2017: 4,360
18
2018: 6,410
19
2019: 6,422
20
2020: 4,282
21
2021: 4,393
22
2022: 4,890
23
2023: 5,700
24
2024: 5,382
25
2025: 1,834