InjuryFEN
MONITOR
Received Apr 6, 2005 · Event occurred Nov 25, 2004
Report 2210968-2005-00190 · MDR key 588083
Device
Generic name
Urodynamics Measurement System
Manufacturer
Ethicon, Inc.Model number
NACatalog number
URP2103
Lot number
04U031
Product problems
- Unknown (for use when the device problem is not known)
Patient
64 YR
- Urinary Tract Infection
- Treatment with medication(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A URODYNAMIC MEASUREMENT PROCEDURE AS PART OF A CLINICAL STUDY IN 2004. POST OPERATIVELY THE PATIENT WAS DIAGNOSED WITH A POSSIBLE URINARY TRACT INFECTION. PATIENT WAS TREATED WITH MEDICATION AND THE PROBLEM WAS RESOLVED THE FOLLOWING MONTH.