MAUDE report

MAUDE report 55595: SILASTIC(R) MAMMARY PROSTHESIS CRONIN ROUND FP SOFT

Injury · received Dec 12, 1996 · DOW CORNING CORP

Key facts

MDR report key 55595
Report number 1816403-1996-00356
Event type Injury
Brand name SILASTIC(R) MAMMARY PROSTHESIS CRONIN ROUND FP SOFT
Catalog number 584
Manufacturer DOW CORNING CORP
Product code FTR
Device class Class III
Date received by FDA Dec 12, 1996
Report date Nov 13, 1996
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
  • 1–9 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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