DeathGZC
VOCARE BLADDER SYSTEM
Received Oct 28, 2005 · Event occurred Feb 6, 2005
Report 9617096-2005-00001 · MDR key 643698
Device
Generic name
Bladder Controller
Manufacturer
Finetech Medical Ltd.Model number
1637-1Catalog number
*
Lot number
*
Product problems
- Unknown (for use when the device problem is not known)
Patient
*
- Death
- Sepsis
Narrative
Description of Event or Problem
REC'D PHONE CALL FROM REPORTER/COORDINATOR REPORTING THAT SHE WAS SCHEDULING FOR ANNUAL F/U VISIT AND LEARNED THAT THE USER HAD DIED OF UROSEPSIS IN 2005 DUE TO REFUSING TREATMENT. COORDINATOR WILL TRY TO DETERMINE IF THE PT'S DEVICE WAS FUNCTIONING AT THE TIME. COORDINATOR STATES THAT WITH TREATMENT THE PT WOULD HAVE MOST LIKELY RECOVERED.
Remedial action
- Other