MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	50T-RESR-MAXX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentioned system was shipped from motion concepts to medbloc (motion concepts usa importer/distributor) on 26-feb-2020 and was then sold to va medical care, (b)(4) on 27-feb-2020.The dealer stated that the issue was caused due to the dip in the driveway & the way the end-user was keeping his legs on the footplate, as his toes were hanging on to the side of the footplate.The end-user is capable of unassisted standing & transferring so that, he is also capable of moving his legs to the center of the footplate.The dealer reminded him to keep the foot centered and also mentioned that the end-user had similar toe injury while using his old wheelchair.The dealer informed us that they are also going to make footplate adjustments so that issues like this won't happen in future.The dealer stated that this was not caused by any system malfunction.However, an injury was involved in this incident so, we consider it as a reportable event.
Event or Problem Description
On 13-apr-2020, motion concepts lp was notified by medbloc inc.(motion concepts usa importer), that one of medbloc's dealers (valaca:vamc, (b)(4)) notified them of an incident that took place on (b)(6) 2020.The dealer reported that there was a dip on end-user's driveway and while he was going down through his driveway, the end-user hit his toe on to the driveway due to the angle on the dip.The dealer mentioned that the end-user scraped his toe, but did not seek any medical attention and it was treated over counter antibiotic.

• Brand Name: POWERED WHEELCHAIR SYSTEM
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): MOTION CONCEPTS LP; 84 citation drive; unit 1-12; concord, on L4K 3 C1; CA L4K 3C1
• MDR Report Key: 10043168
• Report Number: 9615350-2020-00005
• Device Sequence Number: 20219067
• Product Code: ITI
• UDI-Device Identifier: 00754014710393
• UDI-Public: 00754014710393
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2020

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: 50T-RESR-MAXX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2020
• 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 Weight: 68