MAUDE report

MAUDE report 9749: SALINE BREAST IMPLANT

No Answer Provided · received Sep 22, 1994 · UNKNOWN

Key facts

MDR report key 9749
Report number 9749
Event type No Answer Provided
Brand name SALINE BREAST IMPLANT
Manufacturer UNKNOWN
Product code FWM
Device class Class III
Date received by FDA Sep 22, 1994
Report date Sep 16, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1,000+ MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 100–999 Injury reports for this brand
  • 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