MAUDE report

MAUDE report 60883: TEXTURED SALINE-FILL MAMMARY IMPLANT

Injury · received Dec 31, 1996 · MCGHAN MEDICAL CORP

Key facts

MDR report key 60883
Report number 2024601-1996-02503
Event type Injury
Brand name TEXTURED SALINE-FILL MAMMARY IMPLANT
Model number 163
Catalog number 27-163781
Manufacturer MCGHAN MEDICAL CORP
Product code FWM
Device class Class III
Date received by FDA Dec 31, 1996
Report date Dec 3, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 100–999 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