InjuryFEN
MONITORR
Received Apr 5, 2005 · Event occurred Dec 22, 2004
Report 2210968-2005-00180 · MDR key 587835
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
UNKNOWN
- Urinary Tract Infection
- Therapy/non-surgical treatment, additional
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. PT DEVELOPED A URINARY TRACT INFECTION 6 DAYS LATER. THE URINARY TRACT INFECTION WAS RESOLVED WITH ANTIBIOTICS 3 DAYS LATER.