MAUDE report

MAUDE report 12052: MAMMARY IMPALNT, 300 CC

Injury · received Mar 16, 1994 · MCGHAN MEDICAL CORP.

Key facts

MDR report key 12052
Report number MW1001097
Event type Injury
Brand name MAMMARY IMPALNT, 300 CC
Model number STYLE 110
Manufacturer MCGHAN MEDICAL CORP.
Product code FTR
Device class Class III
Date received by FDA Mar 16, 1994
Report date Feb 22, 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
  • 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