MAUDE report

MAUDE report 71158: SALINE-FILL MAMMARY IMPLANT

Injury · received Feb 21, 1997 · MCGHAN MEDICAL CORPORATION

Key facts

MDR report key 71158
Report number 2024601-1997-00043
Event type Injury
Brand name SALINE-FILL MAMMARY IMPLANT
Model number NI
Catalog number NI
Manufacturer MCGHAN MEDICAL CORPORATION
Product code FWM
Device class Class III
Date received by FDA Feb 21, 1997
Report date Jan 24, 1997
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