HURRYCANE

Description of Event or Problem

DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A CANE BRANDED HURRYCANE. WE HAVE RECEIVED NOTIFICATION OF THE INCIDENT FROM THE END-USER'S ATTORNEY. WE HAVE LITTLE INFORMATION AND NO ACCESS TO THE DEVICE. IN AN OVERABUNDANCE OF CAUTION WE ARE FILING THIS MDR. WE INTEND TO UPDATE THIS FILING ONCE ADDITIONAL INFORMATION IS AVAILABLE. THE ATTORNEY HAS REPORTED THAT THE CANE - MODEL UNKNOWN- HAS ALLEGEDLY FAILED CAUSING THE END-USER TO FALL AND FRACTURE HER FEMUR.

Description of Event or Problem

(B)(6) HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A CANE BRANDED HURRYCANE. WE HAVE RECEIVED NOTIFICATION OF THE INCIDENT FROM THE END-USER'S ATTORNEY. WE HAVE LITTLE INFORMATION AND NO ACCESS TO THE DEVICE. IN AN OVERABUNDANCE OF CAUTION WE ARE FILING THIS MDR. WE INTEND TO UPDATE THIS FILING ONCE ADDITIONAL INFORMATION IS AVAILABLE. THE ATTORNEY HAS REPORTED THAT THE CANE - MODEL UNKNOWN- HAS ALLEGEDLY FAILED CAUSING THE END-USER TO FALL AND FRACTURE HER FEMUR. ADDITIONAL INFORMATION ACQUIRED: THE END-USER SUFFERS FROM A CONDITION IS HEREDITARY SPASTIC PARAPLEGIA WHICH IS A RARE INHERITED NEURO DISORDER THAT CREATES MUSCLE WEAKNESS AND TIGHTNESS IN TURN MAKES WALKING DIFFICULT. WHEN PRESENT, WEAKNESS DOES NOT AFFECT ALL LEG MUSCLES, BUT RATHER IS MOST OBVIOUS IN MUSCLES OF HIP FLEXION (ILIOPSOAS), HIP ABDUCTION (GLUTEUS MEDIUS), KNEE FLEXION (HAMSTRINGS), AND FOOT DORSIFLEXION (BENDING THE FOOT BACK TOWARD THE SHIN VIA TIBIALIS ANTERIOR MUSCLE). IT IS REPORTED THAT WHILE SHE WAS USING HER HURRYCANE FREEDOM SUDDENLY 2 OF THE SECTIONS BECAME DETACHED FROM EACH OTHER CAUSING HER TO FALL. HOWEVER, THE INNER CORD REMAINED INTACT,. IT IS UNCLEAR HOW THIS HAPPENED. IT IS BELIEVED THAT SHE STEPPED ON THE BOTTOM OF THE CANE CAUSING THE DETACHMENT OF THE SECTIONS. ROOT CAUSE CANNOT BE DETERMINED FROM THE VIDEO SUPPLIED. HOWEVER, CONSIDERING HER GAIT AND CONDITION A CANE WAS LIKELY INADEQUATE FOR HER NEEDS.