MAUDE report

MAUDE report 11784: SILICONE BREAST IMPLANT, 250 CC

No Answer Provided · received Mar 1, 1994 · MCGHAN MEDICAL CORP.

Key facts

MDR report key 11784
Report number MW1000903
Event type No Answer Provided
Brand name SILICONE BREAST IMPLANT, 250 CC
Model number STYLE 40
Catalog number 25-40250
Manufacturer MCGHAN MEDICAL CORP.
Product code FTR
Device class Class III
Date received by FDA Mar 1, 1994
Report date Feb 4, 1994
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
  • No 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