DeathFMP
MEDICHOICE ULTIMATE OFF LOADING
Received Aug 7, 2014 · Event occurred May 7, 2014
Report 2431497-2014-00001 · MDR key 4184189
Device
Product problems
- Insufficient Device Problem Information
Patient
NA
- Death
- Fall
- Intracranial Hemorrhage
- Laceration(s)
- Confusion/ Disorientation
Narrative
Description of Event or Problem
MALE PT AT A SKILLED NURSING HOME (NOT IDENTIFIED) FOUND ON FLOOR WITH A HEAD LACERATION AND CONFUSION. WAS FOUND TO HAVE SUSTAINED EXTENSIVE INTRACRANIAL HEMORRHAGE DURING FALL. AS NOTED IN VOLUNTARY REPORT NO. (B)(6) (ATTACHED): RESIDENT WAS FOUND ON FLOOR WITH HEAD LACERATION AND CONFUSION CAUSED BY A FALL. RESIDENT WAS FOUND WEARING MEDICHOICE ULTIMATE OFF-LOADING HEEL BOOTS.
Additional Manufacturer Narrative
NOTE: "CAUTION" SECTION ON SECOND PAGE OF INSTRUCTION SHEET PACKAGED IN EVERY ULTIMATE OFF-LOADING HEEL BOOT - COMMENT #2 "DO NOT ALLOW PATIENT TO WALK OR STAND ON THE FLOOR WHILE WEARING THE BOOT".