MAUDE manufacturer profile

SOFRADIM PRODUCTION SAS · FTL

MAUDE profile for Mesh, Surgical, Polymeric

Key facts

Manufacturer SOFRADIM PRODUCTION SAS
Manufacturer group SOFRADIM PRODUCTION SAS
Product code FTL
Product code name Mesh, Surgical, Polymeric

At a glance

  • 1,000+ MAUDE reports
  • 100–999 Death reports
  • 1,000+ Injury reports
  • 100–999 Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Unspecified Tissue Injury, Hernia, Pain, Adhesion(s), Injury, Inflammation, Unspecified Infection Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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