MONITORR
Received Jun 8, 2006 · Event occurred Feb 9, 2006
Report 2210968-2006-00415 · MDR key 724418
Device
Generic name
Urodynamics Measurement System
Manufacturer
Ethicon, Inc.Model number
NACatalog number
MON2100
Lot number
UNK
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
37 YR
- Urinary Tract Infection
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
THE PT UNDERWENT URODYNAMIC MEASUREMENT TESTING IN 2005 FOLLOWED BY A SLING PROCEDURE FOR STRESS URINARY CONTINENCE THE FOLLOWING DAY. THERE WERE NO INTRAOPERATIVE OR IMMEDIATE POSTOPERATIVE COMPLICATIONS AND THE PT WAS DISCHARGED HOME 2 DAYS LATER WITH A NORMAL VOIDING PATTERN. A POSTOPERATIVE URODYNAMIC MEASUREMENT TEST TOOK PLACE IN 2006. A URINARY TRACT INFECTION OF MODERATE SEVERITY WAS REPORTED TO HAVE OCCURRED FOR 4 DAYS. THE PT WAS TREATED WITH CIPROFLOXAXCIN FOR 4 DAY, AND THE EVENT RESOLVED.
Additional Manufacturer Narrative
CONCLUSION: THE PT UNDERWENT MONITORR TESTING IN 2006 AND HAD A URINARY TRACT INFECTION DEVELOP ON THE 2ND DAY. ANY PROCEDURE IN WHICH THE BLADDER OR URETHRA IS INSTRUMENTED (CATHETER, SOUNDS, ETC.) IS ASSOCIATED WITH THE RISK OF THE DEVELOPMENT OF URINARY TRACT INFECTION.