InjuryNXE
DRIVER MEDICAL
Received Aug 10, 2007 · Event occurred Jul 11, 2007
Report 2438477-2007-00002 · MDR key 893206
Device
Product problems
- Detachment Of Device Component
- Component Falling
Patient
90 YR
- Dural Tear
- Fall
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
THE USER ALLEGEDLY WAS TRYING TO SIT ON THE ROLLATOR TO TEST THE PRODUCT WHEN THE LEFT CASTER FELL OUT. SHE CONSEQUENTLY FELL BACKWARDS SUSTAINING SEVERE CUTS ON THE RIGHT CALF AND RIGHT ELBOW. MEDICAL ATTENTION WAS REQUIRED.
Additional Manufacturer Narrative
ALL OUR ROLLATORS ARE DISTRIBUTED WITH ALL CASTERS PREINSTALLED. THE FRONT CASTER FORK IS INSTALLED TO THE FRAME BY AN AXLE BOLT AND LOCK WASHER. ACCORDING TO CUSTOMER, THIS ROLLATOR HAD BEEN USED FOR DEMONSTRATION IN SHOWROOMS FOR MORE THAN TWO YRS. IT APPEARED THAT THE WHEEL CAME LOOSE DUE TO LACK OF MAINTENANCE.