RISK MANAGER
Received Apr 23, 2013 · Event occurred Feb 18, 2013
Report 1041130-2013-00001 · MDR key 3082938
Device
Product problems
- Unintended Collision
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Fall
- Physical Entrapment
Narrative
Description of Event or Problem
THE FACILITY REPORTED, TO OUR SALES REPRESENTATIVE, THAT THE EMPLOYEE CAUGHT HER FOOT ON THE MAT (CORDS FROM A TUBE FEEDING PUMP AND AIR MATTRESS PUMP WERE INVOLVED AS WELL), RESULTING IN A FALL AND KNEE INJURY.
Additional Manufacturer Narrative
OUR SALES REP WAS CONTACTED ON (B)(6) 2013 ABOUT A FALL THAT RESULTED IN A KNEE INJURY. (B)(4), DISTRIBUTOR, VISITED THE FACILITY ON (B)(4) 2013 TO REVIEW OUR PRODUCT (FALL MAT). SHE FOUND THE MATS TO BE IN DECENT SHAPE (BUT DID NOT BELIEVE THIS CONTRIBUTED TO THE FALL). THE EMPLOYEE'S FALL ALSO INVOLVED CORDS FROM A TUBE FEEDING PUMP AS WELL AS AN AIR MATTRESS. IN REVIEW OF OUR POST PRODUCTION RISK MANAGEMENT, WE FOUND THIS TO BE THE SECOND TRIP AND FALL INJURY OVER THE LIFE OF THIS PRODUCT (B)(4). THE LIKELIHOOD OF OCCURENCE IS IMPROBABLE AND HAS AN ACCEPTABLE RISK INDEX THUS NO ACTION WILL BE TAKEN.