MAUDE report

MAUDE report 25859: GEL-FILLED MAMMARY PROSTHESIS

Injury · received Sep 22, 1995 · BAXTER V. MUELLER

Key facts

MDR report key 25859
Report number MW1006973
Event type Injury
Brand name GEL-FILLED MAMMARY PROSTHESIS
Catalog number 350-2110
Manufacturer BAXTER V. MUELLER
Product code FWM
Device class Class III
Date received by FDA Sep 22, 1995
Report date Sep 18, 1995
Report source Maude

At a glance

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

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