PlainHospital

SOFRADIM PRODUCTION SAS

Manufacturer adverse-event records for SOFRADIM PRODUCTION SAS 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 · 2013–2026 · mid-book · elevated Death-code · injury-heavy

Injury-mix signature

SOFRADIM PRODUCTION SAS leans injury-heavy in event_type mix

Injury-coded event_type share is 96.3% (injury-heavy tercile) beside 1.03% Death-coded (elevated). Volume band: mid.

What the Injury-mix reading shows for SOFRADIM PRODUCTION SAS

The standout signal for SOFRADIM PRODUCTION SAS is Injury-mix: 96.3% Injury-coded (injury-heavy) beside 1.03% Death-coded, on a mid-book footprint.

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

Reports span 10 device types, led in this extract by Injury at 19,599 (96.3% of event_type total). Peak single-year volume reaches 3,914 reports across 13 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

20,345
Total Reports
210
Event-type Death
19,599
Injury Reports
10
Device Types

Event Types

Injury 19,599 (96.3%)
Malfunction 536 (2.6%)
Death 210 (1.0%)

Patient Outcomes

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

Required Intervention 14,362 (46.4%)
R 4,165 (13.4%)
S 3,139 (10.1%)
Other 2,512 (8.1%)
O 2,112 (6.8%)
Disability 1,746 (5.6%)
H 914 (3.0%)
Hospitalization 905 (2.9%)
506 (1.6%)
L 277 (0.9%)
Life Threatening 134 (0.4%)
D 107 (0.3%)
Death 96 (0.3%)
Congenital Anomaly 1 (0.0%)

Devices (10)

Device Reports
Mesh, Surgical, Polymeric 19,893
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator 232
Mesh, Surgical 155
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed 38
Mesh, Surgical, Absorbable, Abdominal Hernia 15
Suture, Absorbable, Synthetic, Polyglycolic Acid 6
Staple, Implantable 3
Mesh, Surgical, Deployer 1
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed 1
Wax, Bone 1

Yearly Trend

13
2013: 2
15
2015: 3
16
2016: 3
17
2017: 1,193
18
2018: 2,892
19
2019: 3,914
20
2020: 2,922
21
2021: 2,464
22
2022: 1,249
23
2023: 1,787
24
2024: 1,749
25
2025: 1,429
26
2026: 738

Read our methodology - how this data is sourced, computed, and verified.