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

Model Number	ALLTRACK M3 HD
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Request made to get the chair back for evaluation; we are still waiting for a response.Should the device become available or further information be received, a follow-up report will then be issued.
Event or Problem Description
Mr (b)(6) reports tilting his chair in his bedroom on a flat surface and the chair tipped backward with him still in it.He was not ejected from the chair but was hospitalized for approximately a week and released.

• Brand Name: ALLTRACK M3 HD
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): AMYLIOR INC.; 3190 f.x. tessier; vaudreuil-dorion, quebec J7V 5 V5; CA J7V 5V5
• MDR Report Key: 11922127
• Report Number: 9615410-2021-00003
• Device Sequence Number: 14270162
• Product Code: ITI
• UDI-Device Identifier: 00827482201714
• UDI-Public: 00827482201714
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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 HD
• Device Catalogue Number: atm
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 49 YR
• Patient Weight: 177