MAUDE manufacturer profile

SOFRADIM PRODUCTION SAS · GAM

MAUDE profile for Suture, Absorbable, Synthetic, Polyglycolic Acid

Key facts

Manufacturer SOFRADIM PRODUCTION SAS
Manufacturer group SOFRADIM PRODUCTION SAS
Product code GAM
Product code name Suture, Absorbable, Synthetic, Polyglycolic Acid

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Break, Fungal Infection, Decreased Sensitivity, Prolapse, Abnormal Vaginal Discharge, Taste Disorder, Patient-Device Incompatibility 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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