inforMED
DeathDWQ

TRIVEX

Received Apr 27, 2005

Report 1643264-2005-00017 · MDR key 597486

Device

Generic name

*

Model number

UNK

Catalog number

*

Lot number

*

Product problems

  • Unknown (for use when the device problem is not known)

Patient

UNKNOWN

  • Death
  • Thrombus

Narrative

Description of Event or Problem

REPORTED THROUGH THE YAHOO SMITH & NEPHEW MESSAGE BOARD THAT "THERE WAS A DEATH DUE TO BLOOD CLOT WHICH WAS REPORTED BY VNUS. ACCORDING TO THE REPORT SUBMITTED BY VNUS, TRIVEX WAS ALSO PERFORMED ON THE SAME PATIENT AND COULD NOT DETERMINE WHICH PROCEDURE MAY HAVE CAUSED THE CLOT." WE REVIEWED THE VNUS MDR (2953189-2005-00001) AND CAN FIND NO FURTHER INFORMATION.