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

Model Number ALLTRACK M3

Device Problem Device Tipped Over (2589)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2022

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 307741564
• Report Number: 9615410-2022-00003
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00827482201714
• UDI-Public: 00827482201714
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: ALLTRACK M3
• Device Catalogue Number: atm
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2022
• Initial Date FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male