SOFRADIM PRODUCTION

Manufacturer adverse-event records for SOFRADIM PRODUCTION 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 · 2002–2026 · thin-book · typical Death-code · injury-heavy

Injury-mix signature

SOFRADIM PRODUCTION leans injury-heavy in event_type mix

Injury-coded event_type share is 94.4% (injury-heavy tercile) beside 0.16% Death-coded (typical). Volume band: thin.

What the Injury-mix reading shows for SOFRADIM PRODUCTION

The standout signal for SOFRADIM PRODUCTION is Injury-mix: 94.4% Injury-coded (injury-heavy) beside 0.16% 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 11 device types, led in this extract by Injury at 4,620 (94.4% of event_type total). Peak single-year volume reaches 2,763 reports across 24 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,893
Total Reports
8
Event-type Death
4,620
Injury Reports
11
Device Types

Event Types

Injury 4,620 (94.4%)
Malfunction 205 (4.2%)
Other 33 (0.7%)
26 (0.5%)
Death 8 (0.2%)
No answer provided 1 (0.0%)

Patient Outcomes

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

Other 3,333 (56.8%)
Required Intervention 1,193 (20.3%)
R 726 (12.4%)
316 (5.4%)
O 245 (4.2%)
Hospitalization 30 (0.5%)
Death 11 (0.2%)
S 6 (0.1%)
Disability 5 (0.1%)
L 2 (0.0%)
Life Threatening 2 (0.0%)
H 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

02
2002: 1
03
2003: 6
04
2004: 9
05
2005: 11
06
2006: 26
07
2007: 11
08
2008: 5
09
2009: 40
10
2010: 73
11
2011: 243
12
2012: 944
13
2013: 2,763
14
2014: 329
15
2015: 122
16
2016: 242
17
2017: 40
18
2018: 3
19
2019: 1
21
2021: 3
22
2022: 1
23
2023: 3
24
2024: 5
25
2025: 11
26
2026: 1