MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	45T-12L-RPSB-MAXX
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Medbloc got notified by one of their dealers at (b)(6) on (b)(6) 2018 about an incident that took place on (b)(6) 2018.The dealer reported that the end user got a cut on her calf while the end user's husband was trying to back her up from the table she was at.The joystick, which was retracted while her husband was backing her up, got activated that caused the system to turn and the center mount of the system ended up cutting her calf.Medical attention was need for the end user as there was bleeding on her calf.According to the dealer, the end user wants modification on the chair.

• Brand Name: POWERED WHEELCHAIR SYSTEM
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): MOTION CONCEPTS LP; 84 citation drive; unit 1-7; concord, ontario L4K3C 1; CA L4K3C1
• MDR Report Key: 7541314
• Report Number: 1319669-2018-00004
• Device Sequence Number: 2412694
• Product Code: ITI
• UDI-Device Identifier: 00754014710119
• UDI-Public: 754014710119
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018
• Report Date (Section F): 05/24/2018

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: No Information
• Device Model Number: 45T-12L-RPSB-MAXX
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/10/2018
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 05/11/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2018
• 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 Weight: 88
• Date Report Sent to FDA: 05/24/2018