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

Model Number	ALLTRACK M3
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The end user tipped forward while driving the chair down on a hill.Apparently, at the end of the hill there was a pothole filled with water and the front casters fell into the pothole tipping the chair over.The end user got a foot stuck under the foot pedal (seat belted in): was hospitalized for a day but no physical damage to foot, no sores, nothing broken (x-rays taken).The motors and the joystick were in the water ; motors are still working fine 3 weeks after the accident but joystick was damaged.

• Brand Name: ALLTRACK M3
• Common Device Name: WHEELCHAIR, POWERED
• 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: 15761772
• Report Number: 9615410-2022-00003
• Device Sequence Number: 8221567
• Product Code: ITI
• UDI-Device Identifier: 00827482201714
• UDI-Public: 00827482201714
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2022

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: ALLTRACK M3
• Device Catalogue Number: atm
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2021
• 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: Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male