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

Model Number	ATM3-3S-MP
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	05/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The wheelchair overturned twice with the user inside.The first time (b)(6) 2026, the user was pulling into the driveway when the front wheels slipped and the wheelchair began to tip over completely; the user fell on her right side, hitting her head and elbow, while her knees were scratched and bleeding.The second time (b)(6) 2026, while the user was seated in her wheelchair, the driver made a turn; the wheelchair skidded to the left and tipped over, throwing her against the left door of the van where she became trapped on her side, hitting her head and elbow.Emergency services (911) were called in both cases.She was wearing her seatbelt.

• Brand Name: ALLTRACK M3
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): AMYLIOR INC.; 3190 rue f.-x.-tessier,; vaudreuil-dorion, québec 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, québec J7V 5-V5 ; CA J7V 5V5
• MDR Report Key: 25664234
• Report Number: 9615410-2026-00004
• Device Sequence Number: 10406935
• Product Code: ITI
• UDI-Device Identifier: 00827482201721
• UDI-Public: 00827482201721
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: ATM3-3S-MP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White