MAUDE report

MAUDE report 6684: SILICONE BREAST IMPLANT

Injury · received Oct 7, 1993 · UNKNOWN

Key facts

MDR report key 6684
Report number 6684
Event type Injury
Brand name SILICONE BREAST IMPLANT
Model number UNKNOWN
Catalog number UNKNOWN
Manufacturer UNKNOWN
Product code FTR
Device class Class III
Date received by FDA Oct 7, 1993
Report date Sep 20, 1993
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 100–999 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