MAUDE Adverse Event Report: WU'S TECH (VIETNAM) CO., LTD. DRIVE; POWER MOBILITY

Model Number	SFSCOUT3
Medical Device Problem Codes	Device Unsafe to Use in Environment (2918); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) healthcare is the initial importer of the device which is a three-wheeled power mobility device.The product has not been returned for evaluation.The end-user confirms that there is nothing wrong with the device, however she wants a four wheeled scooter as replacement.The three-wheeled scooter tipped over while user was checking her mail.She was riding down an incline and the device fell on top of her.She broke a rib.She confirmed that nothing is wrong with the scooter she wants a replacement since she believes she should have been given a four wheeled one in the first place.

• Brand Name: DRIVE
• Common Device Name: POWER MOBILITY
• Manufacturer (Section D): WU'S TECH (VIETNAM) CO., LTD.; no.31, vsip ii, road 6; hoa phu ward; tdm city, binh duong province ; VM
• MDR Report Key: 11324217
• Report Number: 2438477-2021-00003
• Device Sequence Number: 3335169
• Product Code: INI
• UDI-Device Identifier: 00822383519081
• UDI-Public: 822383519081
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/12/2021
• Report Date (Section F): 02/12/2021

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: SFSCOUT3
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/08/2021
• Device Age: 22 MO
• Event Location: Other
• Date Report to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2021
• 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: Other
• Patient Age: 79 YR
• Patient Weight: 101
• Date Report Sent to FDA: 02/12/2021