DRIVE MEDICAL
Received Jun 8, 2007 · Event occurred May 10, 2007
Report 2438477-2007-00001 · MDR key 863248
Device
Product problems
- Break
Patient
51 YR
- Fall
- Hip Fracture
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE APPEARED TO BE USED FOR A PERIOD OF TIME. THE RIGHT REAR LEG IS BROKEN OFF COMPLETELY AT WHERE THE LOWER RIVET ATTACHED TO THE SIDE CROSS BAR. THE FOLDING/LATCHING MECHANISM APPEARED TO WORK PROPERLY. WE BELIEVE THAT THE DEVICE BROKE BECAUSE THE USER APPLIED WEIGHT TO ONLY ONE LEG WHILE WALKING ON STEPS. OUR PRODUCT INSTRUCTION HAS A WARNING FOR THE USER NOT TO USE ON STAIRS OR ESCALATORS.
Description of Event or Problem
USER ALLEGEDLY WAS IN THE KITCHEN, WALKED DOWN HALLWAY AND PROCEEDED TO GO UP APPROX NINE (9) STEPS WHEN ALLEGEDLY THE LEG OF THE WALKER ALLEGEDLY SNAPPED AND USER TUMBLED DOWN THE STAIRWAY. USER DOES NOT RECALL THE FALL. USER BROKE HIS RIGHT HIP AND FRACTURED HIS PELVIC BONE. FAMILY MEMBERS CALLED 911. USER WAS TRANSPORTED AND ADMITTED TO HOSP IN 2007. AFTER TREATMENT AND STABILIZATION, USER WAS THEN TRANSPORTED FIVE DAYS LATER TO REHAB. AS OF THREE DAYS LATER, USER WAS STILL IN REHAB.