InjuryFEN
MONITORR
Received Apr 5, 2005 · Event occurred Oct 7, 2004
Report 2210968-2005-00178 · MDR key 587848
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
60 YR
- Pain
- Urinary Tract Infection
- Burning Sensation
- 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 PAINFUL, BURNING URINATION WITH A URINARY TRACT INFECTION. THE PT WAS TREATED WITH AN ANTIBACTERIAL AGENT AND THE SYMPTOMS RESOLVED 8 DAYS LATER.