MAUDE manufacturer profile

ALLERGAN · FWM

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

Key facts

Manufacturer ALLERGAN
Manufacturer group UNKNOWN MANUFACTURER
Product code FWM
Product code name Prosthesis, Breast, Inflatable, Internal, Saline

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 10–99 Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • Pain, Fatigue, Adverse Event Without Identified Device or Use Problem, Patient-Device Incompatibility, Hair Loss, Headache, Anxiety, Arthralgia 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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