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

Model Number	SFSCOUT3
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Wus tech (b)(4) co., ltd.Is the manufacturer of the device which is a three-wheeled power mobility device, and (b)(4) healthcare is the initial importer of the 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): WUS TECH (VIETNAM) CO., LTD.,; no. 31, road 6th, vsip2; hoa phu ward; thu dau mot, binh duong 84000 0; VM 840000
• Manufacturer (Section G): WUS TECH (VIETNAM) CO., LTD.,; no. 31, road 6th, vsip2; hoa phu ward; thu dau mot, binh duong 84000 0; VM 840000
• Manufacturer Contact: minh khoa ben dao ; no. 31, road 6th, vsip2; hoa phu ward; thu dau mot, binh duong 84000-0 ; VM 840000
• MDR Report Key: 13627778
• Report Number: 3007963811-2021-00001
• Device Sequence Number: 12093330
• Product Code: INI
• UDI-Device Identifier: 00822383519081
• UDI-Public: 822383519081
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 101 KG