MAUDE report

MAUDE report 10475: SILASTIC GEL IMPLANT

Injury · received Dec 10, 1993 · DOW CORNING CORP.

Key facts

MDR report key 10475
Report number MW1000099
Event type Injury
Brand name SILASTIC GEL IMPLANT
Catalog number 974
Manufacturer DOW CORNING CORP.
Product code FTR
Device class Class III
Date received by FDA Dec 10, 1993
Report date Nov 28, 1993
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
  • Yes 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