MAUDE manufacturer profile

IDEAL IMPLANT INCORPORATED · FWM

MAUDE profile for Prosthesis, Breast, Inflatable, Internal, Saline

Key facts

Manufacturer IDEAL IMPLANT INCORPORATED
Manufacturer group SPECIALTY SILICONE FABRICATORS
Product code FWM
Product code name Prosthesis, Breast, Inflatable, Internal, Saline

At a glance

  • 1,000+ MAUDE reports
  • 1,000+ Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Deflation Problem, Insufficient Information, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Capsular Contracture, Failure of Implant 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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