Description of Event or Problem · 0
ON (B)(6) 2024, THE USER, WAS ATTEMPTING TO CROSS THE STREET WHEN HE WAS STRUCK BY A VEHICLE WHEN SITTING IN HIS MOTION COMPOSITES HELIO A7 WHEELCHAIR, (B)(6). THE INCIDENT HAPPENED WITHIN THE US MARKET. THE COLLISION IMPACTED BOTH WHEELS OF THE WHEELCHAIR, THE CROSSBAR, AND CAUSED THE WHEEL WITH THE SMARTDRIVE POWER ASSIST TO DETACH. DESPITE THE FORCE OF THE IMPACT, THE USER WAS ABLE TO "THROW" HIMSELF OUT OF THE WHEELCHAIR. HOWEVER, HE SUSTAINED MULTIPLE BUMPS, BRUISES, AND A BROKEN LEG. THE USER REPORTED BEING HOSPITALIZED, UNDER THE CIRCUMSTANCES, HE IS REPORTED TO BE IN STABLE CONDITION. USER INFORMATION AND MULTIPLES CONDITIONS PRIOR TO THE INCIDENT: QUADRIPLEGIA/TETRAPLEGIA, CELLULITIS OF UNSPECIFIED PART OF LIMB, UNSPECIFIED OPEN WOUND, UNSPECIFIED FOOT, INITIAL ENCOUNTER, TYPE 2 DIABETES MELLITUS WITHOUT COMPLICATIONS, OSTEOMYELITIS OF VERTEBRA, CERVICAL REGION. THE USER REPORTED TO HIS HEALTHCARE PROVIDER (HCP) THAT HE HAS A PRIOR SPINAL CORD INJURY IN THE CLAVICLE. HE MENTIONED EXPERIENCING SYMPTOMS IN HIS RIGHT LEG, HAND, AND ARM AS A RESULT OF THE INCIDENT. ADDITIONALLY, HE HAS INDICATED THAT HE HAS LEGAL REPRESENTATION REGARDING THE MATTER. AT THE TIME OF THE INCIDENT, THE WHEELCHAIR WAS EQUIPPED WITH A SMARTDRIVE MX2/162 POWER ASSIST (MODEL: MX2-PUSHTRACKER E2S, HCPIC CODE E0986), WHICH WAS ORDERED ON (B)(6) 2021, AND INSTALLED ON (B)(6) 2021. THE WHEELCHAIR WAS MANUFACTURED ON JUNE 22, 2021. PLEASE NOTE THAT THIS REPORT IS BEING SUBMITTED ON A VOLUNTARY BASIS, IN ACCORDANCE WITH FDA REPORTING REQUIREMENTS. ACCORDING TO THE INFORMATION AVAILABLE TO DATE, THERE IS NO INDICATION THAT THE INCIDENT WAS CAUSED BY A FAILURE OF THE WHEELCHAIR.