DeathISA
ENSEKIGAISEN ONNETSUKI ("ONNETSU")
Received Feb 14, 2011 · Event occurred May 28, 2007
Report 3004057530-2011-00001 · MDR key 1988256
Device
Product problems
- Insufficient Device Problem Information
Patient
59 YR
- Burn(s)
Narrative
Description of Event or Problem
IN A LAWSUIT, THE ESTATE OF (B)(6) ALLEGES THAT HIS DEATH WAS CAUSED BY AN INFECTION CAUSED BY A BURN CAUSED BY HIS HOME HEALTH CARE AIDE'S PERSONAL USE (IT WAS NOT PART OF HIS PRESCRIBED CARE) OF THE ONNETSU DEVICE WHILE MASSAGING HIM ON HIS REMAINING LEG (HIS OTHER HAD BEEN AMPUTATED DUE TO DIABETES). THE AIDE HAS TESTIFIED THAT SHE DID NOT USE THE DEVICE ON HIS LEG AND THAT WHEREVER SHE USED IT ON HIS BODY, SHE USED IT PROPERLY.