MAUDE report

MAUDE report 10805: BILATERAL BREAST IMPLANT, 235 CC

No Answer Provided · received Jan 5, 1994 · DOW CORNING

Key facts

MDR report key 10805
Report number MW1000302
Event type No Answer Provided
Brand name BILATERAL BREAST IMPLANT, 235 CC
Manufacturer DOW CORNING
Product code FTR
Device class Class III
Date received by FDA Jan 5, 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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