MAUDE manufacturer profile

ALLERGAN (ARKLOW) · FTR

MAUDE profile for Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Key facts

Manufacturer ALLERGAN (ARKLOW)
Manufacturer group ALLERGAN (ARKLOW)
Product code FTR
Product code name Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Material Rupture, Failure of Implant, Seroma, No Apparent Adverse Event, Lymphoma, Patient-Device Incompatibility, Capsular Contracture, Adverse Event Without Identified Device or Use Problem 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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