MAUDE report

MAUDE report 9624: CUSTOM 500 CC LOW PROFILE TEXTURED SALINE BREAST IMPLANTS

No Answer Provided · received Aug 2, 1993 · MCGHAN MEDICAL CORPORATION

Key facts

MDR report key 9624
Report number 9624
Event type No Answer Provided
Brand name CUSTOM 500 CC LOW PROFILE TEXTURED SALINE BREAST IMPLANTS
Catalog number 2700168
Manufacturer MCGHAN MEDICAL CORPORATION
Product code FWM
Device class Class III
Date received by FDA Aug 2, 1993
Report date Aug 2, 1993
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
  • 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