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

Model Number SFSCOUT4

Device Problem Device Tipped Over (2589)

Patient Problem Injury (2348)

Event Date 12/01/2018

Event Type  malfunction  

Event Description

(b)(4) is the initial importer of the device which is a power scooter.Our post market department was informed of the incident through a letter from an insurance carrier regarding a potential legal claim.Specifics of the incident and injury are minimal.We do not expect to receive the device back for evaluation.We are filing this report in an overabundance of caution.The end-user was driving the scooter when the left front wheel reportedly fell off and the device tipped over.The end-user claimed to have sustained a knee injury and underwent physical therapy.No medical documentation is available at this time.We will file a followup report if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: POWER MOBILITY
• Manufacturer (Section D): WUS TECH (VIETNAM) CO., LTD.; no. 31-33, road 6th, vsip2; hoa phu ward,; thu dau mot, binh duong ; VM
• Manufacturer Contact: khoa ben dao ; no. 31-33, road 6th, vsip2; hoa phu ward,; thu dau mot, binh duong ; VM
• MDR Report Key: 10048533
• MDR Text Key: 216163889
• Report Number: 3007963811-2019-00002
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SFSCOUT4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2019
• Distributor Facility Aware Date: 06/18/2019
• Device Age: 2 MO
• Event Location: Other
• Date Report to Manufacturer: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization