MAUDE report

MAUDE report 12880: DOUBLE LUMEN SILICONE GEL MAMMARY IMPLANT, 400/460 CC

No Answer Provided · received Apr 21, 1994 · MCGHAN MEDICAL CORP.

Key facts

MDR report key 12880
Report number MW1001687
Event type No Answer Provided
Brand name DOUBLE LUMEN SILICONE GEL MAMMARY IMPLANT, 400/460 CC
Catalog number 25-76400
Manufacturer MCGHAN MEDICAL CORP.
Product code FTR
Device class Class III
Date received by FDA Apr 21, 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
  • None 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