MAUDE report

MAUDE report 12179: REPLICON MAMMARY PROSTHESIS, SIZE 10

No Answer Provided · received Mar 22, 1994 · MEDICAL ENGINEERING CORP.

Key facts

MDR report key 12179
Report number MW1001180
Event type No Answer Provided
Brand name REPLICON MAMMARY PROSTHESIS, SIZE 10
Catalog number 10-355
Manufacturer MEDICAL ENGINEERING CORP.
Product code FTR
Device class Class III
Date received by FDA Mar 22, 1994
Report date Aug 26, 1993
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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