MAUDE report

MAUDE report 77511: SILTEX SALINE

Injury · received Mar 14, 1997 · MENTOR H/S

Key facts

MDR report key 77511
Report number 1645337-1997-00018
Event type Injury
Brand name SILTEX SALINE
Catalog number 354-2640
Manufacturer MENTOR H/S
Product code FWM
Device class Class III
Date received by FDA Mar 14, 1997
Report date Mar 13, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • None Death reports for this brand
  • 10–99 Injury reports for this brand
  • Yes Adverse event flagged
  • No 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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