MAUDE report

MAUDE report 31081: MCGHAN MAMMARY IMPLANT

Injury · received Feb 20, 1995 · MCGHAN MEDICAL CO.

Key facts

MDR report key 31081
Report number 31081
Event type Injury
Brand name MCGHAN MAMMARY IMPLANT
Model number STYLE 40-340 SILICONE GEL
Manufacturer MCGHAN MEDICAL CO.
Product code FTR
Device class Class III
Date received by FDA Feb 20, 1995
Report date Feb 20, 1995
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
  • 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