inforMED
InjuryGZC

VOCARE BLADDER SYSTEM

Received Nov 4, 2004 · Event occurred Aug 6, 2004

Report 9617096-2004-00003 · MDR key 553732

Device

Generic name

Bladder Controller

Model number

1637-1

Catalog number

*

Lot number

*

Product problems

  • Use of Incorrect Control/Treatment Settings

Patient

*

  • Urinary Retention
  • Urinary Tract Infection
  • Treatment with medication(s)

Narrative

Description of Event or Problem

USER IS NOT GETTING PROPER VOIDING FROM THEIR EQUIPMENT. INITIALLY THIS WAS THOUGHT TO BE AN EQUIPMENT FAILURE. DURING DISCUSSION IT WAS REVEALED THAT THE USER HAS GAINED 8 TO 10 POUNDS RECENTLY, THIS WOULD EXPLAIN THE LACK OF STIMULATION AND THE USER WAS ADVISED THAT THE EQUIPMENT WOULD NEED ADJUSTING TO GIVE PROPER STIMULATION. THE USER ADVISED THAT THEIR DOCTOR WAS NOT COMFORTABLE WITH MAKING THE ADJUSTMENTS AND IT WAS DECIDED TO CONTACT DR WHO IS A SPECIALIST IN VOCARE TO HELP. DURING THE TIME THAT IT TOOK TO CONTACT DR THE USER DEVELOPED A UTI WHICH IS BEING TREATED.