MAUDE report

MAUDE report 620: MAMMARY IMPLANTS GEL-FILLED

Malfunction · received May 21, 1992 · MCGHAN MEDICAL CORPORATION

Key facts

MDR report key 620
Report number 620
Event type Malfunction
Brand name MAMMARY IMPLANTS GEL-FILLED
Model number 180 CC ROUND SILASTIC
Catalog number 25/80/180
Manufacturer MCGHAN MEDICAL CORPORATION
Product code FTR
Device class Class III
Date received by FDA May 21, 1992
Report date May 7, 1992
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