MAUDE manufacturer profile

COLOPLAST A/S · FAF

MAUDE profile for Prosthesis, Testicular

Key facts

Manufacturer COLOPLAST A/S
Manufacturer group MINNEAPOLIS
Product code FAF
Product code name Prosthesis, Testicular

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Fluid/Blood Leak, No Information, Inadequacy of Device Shape and/or Size, Deflation Problem, Adverse Event Without Identified Device or Use Problem, Leak/Splash, Insufficient Information 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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