MAUDE Adverse Event Report: AMYLIOR INC. ALLTRACK R3; WHEELCHAIR, POWERED

Model Number	ATR3-3S-MP
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The end user hit something or the right motor just stopped working, the chair pulled to the right (just the left hand side motor working) and fell off of the curb ejecting the user out of the chair.No injuries, no hospitalisation.Only damage after inspection was a bent r/h fork.

• Brand Name: ALLTRACK R3
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): AMYLIOR INC.; 3190 rue f.-x.-tessier; vaudreuil-dorion, quebec J7V 5 V5; CA J7V 5V5
• Manufacturer (Section G): AMYLIOR INC.; 3190 f.x. tessier; vaudreuil-dorion, quebec J7V 5 V5; CA J7V 5V5
• Manufacturer Contact: eric dugas ; 3190 f.x. tessier; vaudreuil-dorion, quebec J7V 5-V5 ; CA J7V 5V5
• MDR Report Key: 24055140
• Report Number: 9615410-2025-00001
• Device Sequence Number: 9465786
• Product Code: ITI
• UDI-Device Identifier: 00827482201714
• UDI-Public: 00827482201714
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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: ATR3-3S-MP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2007
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Male