InjuryFEN
MONITORR
Received Apr 6, 2005 · Event occurred Oct 13, 2004
Report 2210968-2005-00186 · MDR key 588113
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
25 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 WAS DIAGNOSED WITH HAVING A URINARY TRACT INFECTION, AND WAS TREATED WITH AN ANTIBACTERIAL AGENT FOR SEVEN DAYS.