MAUDE report

MAUDE report 30731: SALINE FILL MAMMARY IMPLANT

Injury · received Jan 16, 1996 · MCGHAN MEDICAL

Key facts

MDR report key 30731
Report number 30731
Event type Injury
Brand name SALINE FILL MAMMARY IMPLANT
Model number STYLE 168
Manufacturer MCGHAN MEDICAL
Product code FWM
Device class Class III
Date received by FDA Jan 16, 1996
Report date Oct 2, 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
  • 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