DeathLEJ
SUNDASH
Received May 11, 2012 · Event occurred May 6, 2012
Report 2311923-2012-00018 · MDR key 2574845
Device
Product problems
- Insufficient Device Problem Information
Patient
50 YR
- Death
Narrative
Additional Manufacturer Narrative
PT DEATH OCCURRED IN THE SAME ROOM THE DEVICE WAS LOCATED IN. CAUSE OF DEATH HAS NOT BEEN DETERMINED YET AND MDR IS BEING SUBMITTED PRECAUTIONARY REASONS, AND FOR COMPLIANCE WITH THE FDA EVEN THOUGH IT HAS NOT BEEN CONFIRMED IF THE DEVICE CAUSED OR CONTRIBUTED TO DEATH. THE DEVICE WAS INSPECTED BY (B)(4) (JK PRODUCTS REP), (B)(4), AND (B)(6) MEDICAL EXAMINERS AND NO HAZARDOUS ISSUES WERE FOUND.
Description of Event or Problem
PT WAS FOUND DECEASED IN THE SAME ROOM AS DEVICE, BUT OUTSIDE OF DEVICE BY SALON ATTENDANT.