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

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	09/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Wus tech (vietnam) is the manufacturer and drive devilbiss healthcare is the initial importer of the device which is a power wheelchair.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.We will submit additional data when it becomes available.The customer stated she doesn't think she is suited for one wheel scooters in the front and is unhappy with them.When she is driving it the wheels are hard and she can feel the bumps and has bruises on her body with every step.The end-user was attempting to make a left turn while using the device.She reported that the wheels got stuck and she tried to stop the momentum of the device wit her left leg.There was some swelling of the leg and complained that her bones hurt.She went to the hospital for x-rays.A second incident occurred while she was going to therapy with the scooter.She came off the bus and turned right to cross the street.When she turned to her left the device flipped over and landed on her.She went to the doctor there was some bruising and swelling on the customers legs and hip.The end user will do physical therapy on her leg.

• Brand Name: DRIVE
• Common Device Name: POWER WHEELCHAIR
• 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: 13728610
• Report Number: 3007963811-2021-00002
• Device Sequence Number: 4710087
• Product Code: INI
• UDI-Device Identifier: 00822383519081
• UDI-Public: 822383519081
• Combination Product (Y/N): Y
• PMA/510(K) Number: K032488
• 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): 10/11/2021

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: 02/11/2020
• Initial Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 74 KG