inforMED
InjuryFEN

MONITORR

Received Apr 6, 2005 · Event occurred Oct 3, 2004

Report 2210968-2005-00185 · MDR key 588151

Device

Generic name

Urodynamics Measurement System

Manufacturer

Ethicon, Inc.

Model number

NA

Catalog number

URP2103

Lot number

04U034

Patient

59 YR

  • Urinary Tract Infection
  • Treatment with medication(s)

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A URODYNAMIC MEASUREMENT PROCEDURE AS PART OF A CLINICAL STUDY IN 2004. 2 DAYS LATER, THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION. ANTIBIOTICS WERE PRESCRIBED AND THE SYMPTOMS WERE RESOLVED 5 DAYS LATER.