MAUDE report

MAUDE report 64322: SILASTIC GREAT TOE IMPLANT H.P. (SWANSON DESIGN)

Injury · received Jan 17, 1997 · DOW CORNING CORP.

Key facts

MDR report key 64322
Report number 1816403-1997-00011
Event type Injury
Brand name SILASTIC GREAT TOE IMPLANT H.P. (SWANSON DESIGN)
Catalog number 4830003
Manufacturer DOW CORNING CORP.
Product code KWH
Device class Class II
Date received by FDA Jan 17, 1997
Report date Dec 16, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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:

Browse all MAUDE medical device reports