MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	50T-RESR-MAXX
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On 23-jan-2018, medbloc was notified by one of its dealer (b)(6) regarding the following incident that took place on (b)(6) 2018.The end user pulled up to his desk and lifted the armrest and the armrest dropped when released.The end user was off balance when the armrest dropped and fell forward and his forearm hit the adductor.The end user got a bruise on his forearm as a result of hitting the adductor.

• 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: 7244877
• Report Number: 1319669-2018-00001
• Device Sequence Number: 10804308
• Product Code: ITI
• UDI-Device Identifier: 00754014710393
• UDI-Public: 00754014710393
• 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): 02/06/2018
• Report Date (Section F): 02/06/2018

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?: Yes
• Operator of Device: No Information
• Device Model Number: 50T-RESR-MAXX
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/23/2018
• Device Age: 10 MO
• Date Report to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2018
• 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: Other
• Patient Age: 67 YR
• Patient Weight: 75
• Date Report Sent to FDA: 02/06/2018