MONITORR
Received Aug 17, 2005 · Event occurred Jul 6, 2005
Report 2210968-2005-00496 · MDR key 627460
Device
Generic name
Urodynamics Measurement System
Manufacturer
Ethicon, Inc.Model number
NACatalog number
URP2103
Lot number
AVL04U037
Product problems
- Unknown (for use when the device problem is not known)
Patient
59 YR
- Bacterial Infection
- Urinary Tract Infection
- Treatment with medication(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PT UNDERWENT A URODYNAMIC MEASUREMENT PROCEDURE ON 06/2005. THE PT PRESENTED SIX DAYS LATER FOR THEIR VOIDING TRIAL. AT THAT TIME, A URINE SPECIMEN WAS TAKEN FROM THEIR FOLEY CATHETER. THE REPORT SHOWED >100,000 E COLI AND >100,000 PSEUDOMONAS AERUGINOSA. THE PT WAS TREATED WITH LEVAQUIN 500 MG DAILY FOR 7 DAYS AND WHEN THE PT RETURNED TO THE OFFICE SIX DAYS LATER FOR A CATHED URINARY ANALYSIS, THE RESULTS WERE NORMAL. THE PHYSICIAN DOES NOT BELIEVE THAT THE URINARY TRACT INFECTION IS RELATED TO THE DEVICE.