MAUDE Adverse Event Report: AMYLIOR INC. ALLTRACK R3; POWER WHEELCHAIR

Model Number	ALLTRACK R3
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Crushing Injury (1797)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Official date of event is unknown.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) was visiting the beach; one the casters shredded, he slammed into the curb and the chair flipped over him.

• Brand Name: ALLTRACK R3
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): AMYLIOR INC.; 3190 f.x. tessier; vaudreuil-dorion, quebec J7V 5V5; CA J7V 5V5
• MDR Report Key: 11614593
• Report Number: 9615410-2021-00001
• Device Sequence Number: 11553497
• Product Code: ITI
• UDI-Device Identifier: 00827482201738
• UDI-Public: 00827482201738
• 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): Y
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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 R3
• Device Catalogue Number: atr
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 04/05/2021
• 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: Death