MAUDE report

MAUDE report 1415: MAMMARY PROSTHESIS - SILICONE GEL

Injury · received Sep 22, 1992 · MCGHAN MEDICAL CORPORATION

Key facts

MDR report key 1415
Report number 1415
Event type Injury
Brand name MAMMARY PROSTHESIS - SILICONE GEL
Model number 25-40261
Catalog number UNKNOWN
Manufacturer MCGHAN MEDICAL CORPORATION
Product code FTR
Device class Class III
Date received by FDA Sep 22, 1992
Report date Sep 9, 1992
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
  • 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