MAUDE Adverse Event Report: LERADO ZHONGSHAN PEACEFUL COVE BUSINESS TRADING CO DRIVE; POWERED WHEELCHAIR

Model Number	SFPRO417FS-2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a power mobility scooter.The device has not been returned for evaluation.In an overabundance of caution we are filing this report.We will submit a followup report if any additional data becomes available.While the customer was crossing the street without using a curb when both wheels and axel came off device from the rear apparatus.She fell in the street,hit her head,and went to the hospital.She did not have any serious injuries, only a stiff neck.She uses the device as an alternative to taking an uber or bus.

• Brand Name: DRIVE
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): LERADO ZHONGSHAN PEACEFUL COVE BUSINESS TRADING CO; no.26, guangfu road,; dong shen; zhong shan, guangdong 52841 4; CH 528414
• MDR Report Key: 12201881
• Report Number: 2438477-2021-00029
• Device Sequence Number: 14734473
• Product Code: ITI
• UDI-Device Identifier: 00822383991788
• UDI-Public: 822383991788
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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: SFPRO417FS-2
• Distributor Facility Aware Date: 07/06/2021
• Device Age: 9 MO
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2021
• 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: Hospitalization
• Patient Age: 77 YR
• Patient Weight: 79