InjuryFEN
MONITOR
Received Jul 26, 2005 · Event occurred Jun 20, 2005
Report 2210968-2005-00458 · MDR key 622765
Device
Generic name
Urodynamics Measurement System
Manufacturer
Ethicon, Inc.Model number
NACatalog number
URP2103
Lot number
AVL04U037
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
67 YR
- Urinary Tract Infection
- Urinary Tract Infection
- Urinary Frequency / Polyuria
- Treatment with medication(s)
Narrative
Description of Event or Problem
THE PT UNDERWENT A URODYNAMIC MEASUREMENT IN 2005 DURING A CLINICAL STUDY. ABOUT A MONTH LATER, THE PT COMPLAINED OF URINARY FREQUENCY, URGENCY, AND URGE INCONTINENCE, AND WAS CONFIRMED TO HAVE A URINARY TRACT INFECTION OF ENTEROCOCCUS. THE PT WAS TREATED WITH LEVAQUIN 500 MG FOR SEVEN DAYS, AND RETURNED TO THE OFFICE A WEEK LATER IMPROVED BUT WITH SOME RESIDUAL URGE INCONTINENCE.