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

Model Number ALLTRACK R3

Device Problem Insufficient Information (3190)

Patient Problem Crushing Injury (1797)

Event Type  Death  

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 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
• Type of Device: POWER WHEELCHAIR
• Manufacturer (Section D): AMYLIOR INC.; 3190 f.x. tessier; vaudreuil-dorion, quebec J7V 5V5; CA J7V 5V5
• Manufacturer (Section G): ERIC DUGAS; 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: 11614593
• MDR Text Key: 243787561
• Report Number: 9615410-2021-00001
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00827482201738
• UDI-Public: 00827482201738
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: ALLTRACK R3
• Device Catalogue Number: atr
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2017
• 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): Death