MAUDE Adverse Event Report: AMYLIOR INC. ALLTRACK HD3 PWR WCHAIR; WHEELCHAIR, POWERED

Model Number	ATHD3-3VHD-SP
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
User in his wheelchair was involved in an accident, but we do not have details of how or when he fell out of the chair.He leans heavily to the left side, drives the chair up and down the street, and the story we got was he was traversing a sidewalk and tried to go over a curb that was too high.He was not hospitalized and there are no bruises.

• Brand Name: ALLTRACK HD3 PWR WCHAIR
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): AMYLIOR INC.; 3190 rue f.-x.-tessier; vaudreuil-doriop, quebec J7V 5 V5; CA J7V 5V5
• Manufacturer (Section G): AMYLIOR INC.; 3190 rue f.-x.-tessier; vaudreuil-dorion, québec J7V 5 V5; CA J7V 5V5
• Manufacturer Contact: eric dugas ; 3190 rue f.-x.-tessier; vaudreuil-dorion, quebec J7V 5-V5 ; CA J7V 5V5
• MDR Report Key: 24483847
• Report Number: 9615410-2026-00002
• Device Sequence Number: 5104493
• Product Code: ITI
• UDI-Device Identifier: 00827482201721
• UDI-Public: 00827482201721
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K092225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: ATHD3-3VHD-SP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 185 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American