MAUDE report

MAUDE report 33755: MAMMARY PROSTHESIS - SALINE

Malfunction · received May 3, 1996 · MENTOR H/S

Key facts

MDR report key 33755
Report number 33755
Event type Malfunction
Brand name MAMMARY PROSTHESIS - SALINE
Model number 1600 ROUND
Catalog number 350-1630
Manufacturer MENTOR H/S
Product code FWM
Device class Class III
Date received by FDA May 3, 1996
Report date May 2, 1996
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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