InjuryFPS
ROSCOE MEDICAL
Received Feb 20, 2018 · Event occurred Sep 5, 2014
Report 3012316249-2018-00006 · MDR key 7283562
Device
Generic name
Deluxe Powder Coated Bed Rail
Product problems
- Detachment Of Device Component
Patient
Not reported
- Fall
- Bone Fracture(s)
- Fall
- Bone Fracture(s)
Narrative
Description of Event or Problem
THE END-USER WAS AT HER HOME AND ATTEMPTED TO AMBULATE FROM HER BED TO THE COMMODE WHEN A BED RAIL ATTACHED TO HER BED CAME APART OR OTHERWISE MALFUNCTIONED, CAUSING HER TO FALL. THE END-USER SUSTAINED AN OBLIQUE FRACTURE THROUGH THE DISTAL DIAPHYSIS OF THE RIGHT FIBULA, AN EQUINUS DEFORMITY OF THE FOOT, AND COMPLICATIONS RESULTING FROM INTERNAL IMPLANTATION OF AN ORTHOPEDIC DEVICE.