MAUDE report

MAUDE report 10632: SALINE INFLATABLE ROUND BREAST IMPLANT, 425 AND 25 CC

No Answer Provided · received Dec 21, 1993 · MENTOR CORP.

Key facts

MDR report key 10632
Report number MW1000201
Event type No Answer Provided
Brand name SALINE INFLATABLE ROUND BREAST IMPLANT, 425 AND 25 CC
Model number 188
Catalog number 350-1870M
Manufacturer MENTOR CORP.
Product code FWM
Device class Class III
Date received by FDA Dec 21, 1993
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