MAUDE report

MAUDE report 17126: SURGITEK MAMMARY IMPLANT, 300 CC

No Answer Provided · received Oct 24, 1994 · MEDICAL ENGINEERING CORP.

Key facts

MDR report key 17126
Report number MW1003785
Event type No Answer Provided
Brand name SURGITEK MAMMARY IMPLANT, 300 CC
Catalog number 10140000S0, 10640000S0
Manufacturer MEDICAL ENGINEERING CORP.
Product code FTR
Device class Class III
Date received by FDA Oct 24, 1994
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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