MAUDE report

MAUDE report 19339: HEYER SHULTE OVAL BREAST IMPLANT, 225 CC

No Answer Provided · received Feb 2, 1995 · V. MUELLER DIV. BAXTER HEALTHCARE CORP.

Key facts

MDR report key 19339
Report number MW1004994
Event type No Answer Provided
Brand name HEYER SHULTE OVAL BREAST IMPLANT, 225 CC
Model number 1900
Catalog number 350-1930
Manufacturer V. MUELLER DIV. BAXTER HEALTHCARE CORP.
Product code FTR
Device class Class III
Date received by FDA Feb 2, 1995
Report date Feb 2, 1995
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
  • None 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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