MAUDE report

MAUDE report 21404: SALINE-FILLED MAMMARY IMPLANT

Other · received Apr 12, 1995 · MENTOR

Key facts

MDR report key 21404
Report number 21404
Event type Other
Brand name SALINE-FILLED MAMMARY IMPLANT
Catalog number 354-2660
Manufacturer MENTOR
Product code FWM
Device class Class III
Date received by FDA Apr 12, 1995
Report date Apr 12, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes Adverse event flagged
  • No Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

Browse all MAUDE medical device reports