MAUDE report

MAUDE report 46245: MCGHAN MEDICAL SALINE BREAST IMPLANTS

Injury · received Jul 31, 1996 · MCGHAN MEDICAL CORP.

Key facts

MDR report key 46245
Report number 46245
Event type Injury
Brand name MCGHAN MEDICAL SALINE BREAST IMPLANTS
Model number STYLE 168-R, STYLE 168-1
Catalog number R-#27-168391, L-#27168391
Manufacturer MCGHAN MEDICAL CORP.
Product code FWM
Device class Class III
Date received by FDA Jul 31, 1996
Report date Jun 27, 1996
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
  • 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