MAUDE report

MAUDE report 26717: SILASTIC HIGH PROFILE GEL-FILLED MAMMARY IMPLANT, 600 CC

Injury · received Oct 10, 1995 · DOW CORNING

Key facts

MDR report key 26717
Report number MW1007284
Event type Injury
Brand name SILASTIC HIGH PROFILE GEL-FILLED MAMMARY IMPLANT, 600 CC
Catalog number P015-0600
Manufacturer DOW CORNING
Product code FTR
Device class Class III
Date received by FDA Oct 10, 1995
Report date Sep 18, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 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