Sofradim Production SAS
FDA adverse event reports naming Sofradim Production SAS as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SOFRADIM PRODUCTION SAS.
- Total reports
- 20,272
- Deaths
- 199
- Injuries
- 19,540
- Malfunctions
- 533
Reports per year
213
315
316
1,19317
2,89218
3,91419
2,92320
2,46521
1,24922
1,78723
1,75024
1,42925
66226
Source: FDA adverse event reports by year received, 2013–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Mesh, Surgical, PolymericFTL19,822
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorOTN232
- Mesh, SurgicalFTM155
- Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally PlacedOTP38
- Mesh, Surgical, Absorbable, Abdominal HerniaOWT13
- Suture, Absorbable, Synthetic, Polyglycolic AcidGAM6
- Staple, ImplantableGDW3
- Wax, BoneMTJ1
- Mesh, Surgical, DeployerORQ1
- Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally PlacedOTO1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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