MalfunctionGZC
VOCARE BLADDER SYSTEM
Received Mar 3, 2006
Report 9617096-2006-00001 · MDR key 682455
Device
Generic name
Bladder Controller
Manufacturer
Finetech MedicalModel number
1637-1Catalog number
*
Lot number
*
Product problems
- Device Issue
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
USER CALLED TO SAY THAT HER VOCARE HAD NOT WORKED FOR SEVERAL YEARS. THIS WAS DISCUSSED WITH DR. G CREASEY SEVERAL YEARS AGO AND THE POSSIBLE NEED FOR REVISION SURGERY WAS DISCUSSED. AT THAT TIME THE USER WAS SUFFERING FROM HEALTH PROBLEMS AND COULD NOT GO AHEAD. NOW THE USER IS IN GOOD HEALTH AGAIN AND WOULD LIKE TO HAVE THE POSSIBLE FAILURE INVESTIATED.