KI
Received Jul 21, 2026 · Event occurred Feb 18, 2022
Report 3005905321-2026-00007 · MDR key 25895489
Device
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
ON (B)(6) 2022 THE USER WAS TRAVELING, WITH THE WHEELCHAIR AND ELECTRIC PROPELLER INSERTED AS DESCRIBED ABOVE, ON A PAVED ROAD IN THE CENTER OF (B)(6) WHEN THE FRONT WHEELS GOT STUCK IN A HOLE. THE SUDDEN BLOCK CAUSED THE WHEELCHAIR TO TIP OVER FROM THE FRONT. THE USER SUFFERED A FRACTURE OF THE METATARSALS IN THE FALL. FRACTURE TO BE ASCERTAINED AFTER THE MRI ON THURSDAY (B)(6) 2022. PER EMAIL FROM DEALER SINCE WE ARE AT THE END OF THE 15TH DAY FROM THE INCIDENT, WE WOULD LIKE TO KNOW IF KI MOBILITY INTENDS TO TREAT THE INCIDENT AS AN ACCIDENT, WITH THE REGISTRATIONS OF THE CASE ON THE WEBSITE OF THE ITALIAN MINISTRY OR IF IT IS TO BE TREATED AS AN UNPLEASANT EPISODE. AFTER RETROSPECTIVE REVIEW OF COMPLAINTS, THIS REPORT WILL BE FILED IN ABUNDANCE OF CAUTION BECAUSE RECORD WAS NOT REPORTED. NO ADDITIONAL INFORMATION OR COMMUNICATION WITH THE END USER AFTER THE INITIAL REPORT. REPLACEMENT PARTS WERE PROVIDED. COMPLAINT INVESTIGATION REPORT HAS NOT BEEN RETURNED FOR FURTHER EVALUATION.
Description of Event or Problem
DEALER STATED ACCIDENT WAS CAUSED BY ANTERIOR OVERTURNING OF THE WHEELCHAIR. PROVIDED FURTHER INFO- DEALER HAS BENOIT LIGHT DRIVE SYSTEM ON CHAIR WHILE THE USER WAS TRAVELING WITH THE ELECTRIC PROPELLER IN USE THE FRONT CASTERS GOT STUCK IN A HOLE. THIS CAUSED THE WHEELCHAIR TO TIP OVER TOWARDS THE FRONT. INJURIES NOTED BELOW IN ADDITIONAL INFO. REPORTED TO KI (B)(6) 2022, DEALER CONFIRMED IT HAPPENED ON (B)(6) 2022, HAPPENED IN (B)(6) ON A PAVED ROAD.