MAUDE report

MAUDE report 1419: MAMMARY PROSTHESIS - SILICONE GEL

Injury · received Sep 22, 1992 · DOW CORNING

Key facts

MDR report key 1419
Report number 1419
Event type Injury
Brand name MAMMARY PROSTHESIS - SILICONE GEL
Model number H041069
Catalog number UNKNOWN
Manufacturer DOW CORNING
Product code FTR
Device class Class III
Date received by FDA Sep 22, 1992
Report date Sep 10, 1992
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
  • 10–99 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