MAUDE report

MAUDE report 52292: SILASTIC(R) II MAMMARY IMPLANTS, H.P.

Injury · received Nov 25, 1996 · DOW CORNING CORP

Key facts

MDR report key 52292
Report number 1816403-1996-00324
Event type Injury
Brand name SILASTIC(R) II MAMMARY IMPLANTS, H.P.
Catalog number UNK
Manufacturer DOW CORNING CORP
Product code FTR
Device class Class III
Date received by FDA Nov 25, 1996
Report date Oct 31, 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
  • 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:

Browse all MAUDE medical device reports