MAUDE report

MAUDE report 13108: LOW PROFILE SILICONE BREAST IMPLANT, 280 CC

No Answer Provided · received May 5, 1994 · DOW CORNING CORP.

Key facts

MDR report key 13108
Report number MW1001865
Event type No Answer Provided
Brand name LOW PROFILE SILICONE BREAST IMPLANT, 280 CC
Catalog number P014-280
Manufacturer DOW CORNING CORP.
Product code FTR
Device class Class III
Date received by FDA May 5, 1994
Report date May 2, 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:

Browse all MAUDE medical device reports