MAUDE Adverse Event Report: AMYLIOR INC. ALLTRACK M3 HD PWR WCHAIR; POWER WHEELCHAIR

Model Number	ATM3-3HD-MP
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user flipped out of his chair (b)(6) 2025.He was going up his ramp on his wheelchair-accessible van and the chair started sliding backwards, eventually tipping over; this caused him to hit his head on the concrete.He went to the er for tests, was released to go home and after a few days, needed to go back to the er, to be diagnosed with a concussion.

• Brand Name: ALLTRACK M3 HD PWR WCHAIR
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): 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: 24054819
• Report Number: 9615410-2026-00001
• Device Sequence Number: 9856770
• Product Code: ITI
• UDI-Device Identifier: 00827482201721
• UDI-Public: 00827482201721
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

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: ATM3-3HD-MP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization
• Patient Sex: Male