MAUDE report

MAUDE report 15526: GIANTURCO-ROUBIN FLEX STENT

Injury · received Jul 21, 1994 · COOK, INC.

Key facts

MDR report key 15526
Report number 15526
Event type Injury
Brand name GIANTURCO-ROUBIN FLEX STENT
Catalog number GRBS-3.5-20
Manufacturer COOK, INC.
Product code MJR
Date received by FDA Jul 21, 1994
Report date Mar 10, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1–9 MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 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:

Browse all MAUDE medical device reports