RISK MANAGER
Received Aug 7, 2012 · Event occurred Jul 11, 2012
Report 1041130-2012-00001 · MDR key 2704464
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Fall
- Hip Fracture
Narrative
Description of Event or Problem
THE FACILITY REPORTED TO OUR SALES REP, THAT THE PT CAUGHT HIS FOOT ON THE EDGE OF THE MAT, TRIPPED, RESULTING IN A FALL AND BROKEN HIP.
Additional Manufacturer Narrative
OUR SALES REP WAS CONTACTED ON (B)(6) 2012 ABOUT A FALL THAT RESULTED IN A BROKEN HIP. HE VISITED THE FACILITY ON (B)(6) 2012 TO REVIEW OUR PRODUCT (FALL MAT). HE FOUND THE MATS TO BE IN GOOD SHAPE AND LYING FLAT ON THE FLOOR. THE MAT WILL REMAIN IN USE AT THIS FACILITY; HOWEVER, THEY WILL REMOVE THE MAT BEFORE TRANSFERRING THE PT TO/FROM BED IF THEY FEEL THE PT CANNOT STEP OVER THE EDGE PROPERLY. IN REVIEW OF OUR POST PRODUCTION RISK MANAGEMENT, WE FOUND THIS TO BE THE ONLY TRIP AND FALL INJURY OVER THE LIFE OF THIS PRODUCT (B)(4). THE LIKELIHOOD OF OCCURRENCE IS IMPROBABLE AND HAS AN ACCEPTABLE RISK INDEX, THUS NO ACTION WILL BE TAKEN.