MAUDE manufacturer profile

MOTIVA USA LLC · LCJ

MAUDE profile for Tissue Expander And Accessories

Key facts

Manufacturer MOTIVA USA LLC
Manufacturer group ESTABLISHMENT LABS S.A.
Product code LCJ
Product code name Tissue Expander And Accessories

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Break, No Clinical Signs, Symptoms or Conditions, Breast Discomfort/Pain, Unspecified Infection, Unintended Deflation, Insufficient Information, Seroma 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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