MAUDE report

MAUDE report 16017: SILTEX LOW BLEED GEL-MAMMARY PROSTHESIS, 400 CCS

No Answer Provided · received Sep 12, 1994 · MENTOR CORP.

Key facts

MDR report key 16017
Report number MW1003313
Event type No Answer Provided
Brand name SILTEX LOW BLEED GEL-MAMMARY PROSTHESIS, 400 CCS
Catalog number 354-4007
Manufacturer MENTOR CORP.
Product code FTR
Device class Class III
Date received by FDA Sep 12, 1994
Report date Sep 12, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 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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