InjuryFEN
MONITORR
Received Apr 4, 2005 · Event occurred Nov 1, 2004
Report 2210968-2005-00177 · MDR key 587397
Device
Generic name
Urodynamics Measurement System
Manufacturer
Ethicon, Inc.Model number
NACatalog number
URP2103
Lot number
04U034
Product problems
- Unknown (for use when the device problem is not known)
Patient
63 YR
- Urinary Tract Infection
- Treatment with medication(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PT UNDERWENT A URODYNAMIC MEASUREMENT PROCEDURE AS PART OF A CLINICAL STUDY IN 2004. POST OPERATIVELY THE PT EXPERIENCED A URINARY TRACT INFECTION, AND WAS TREATED WITH AN ANTIBACTERIAL AGENT. THE PT'S SYMPTOMS WERE RESOLVED AS 7 DAYS LATER.