MAUDE report

MAUDE report 36492: INFLATABLE MAMMARY PROSTHESIS

Injury · received Aug 30, 1996 · BAXTER-SURGICAL GROUP

Key facts

MDR report key 36492
Report number 1923569-1996-00014
Event type Injury
Brand name INFLATABLE MAMMARY PROSTHESIS
Model number 350-1850
Catalog number 350-1850
Manufacturer BAXTER-SURGICAL GROUP
Product code FTR
Device class Class III
Date received by FDA Aug 30, 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
  • None 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:

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