MAUDE report

MAUDE report 38410: UNKNOWN MAMMARY PROSTHESIS

Injury · received Sep 18, 1996 · AMERICAN HEYER SCHULTE/V MUELLER DIV.

Key facts

MDR report key 38410
Report number 42933-1996-00054
Event type Injury
Brand name UNKNOWN MAMMARY PROSTHESIS
Model number UNK
Catalog number UNK
Manufacturer AMERICAN HEYER SCHULTE/V MUELLER DIV.
Product code FWM
Device class Class III
Date received by FDA Sep 18, 1996
Report date Sep 18, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • None Death reports for this brand
  • 10–99 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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