MAUDE report

MAUDE report 31927: HEYER SCHULTE GEL-FILLED MAMMARY PROSTHESIS

Injury · received Apr 9, 1996 · V. MUELLER DIV. BAXTER HEALTHCARE CORP.

Key facts

MDR report key 31927
Report number MW1008844
Event type Injury
Brand name HEYER SCHULTE GEL-FILLED MAMMARY PROSTHESIS
Model number C5620
Catalog number 2100
Manufacturer V. MUELLER DIV. BAXTER HEALTHCARE CORP.
Product code FTR
Device class Class III
Date received by FDA Apr 9, 1996
Report date Apr 1, 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
  • 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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