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

Model Number	SFSCOUT4
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Event or Problem 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 the 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
• 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: 8800939
• Report Number: 2438477-2019-00036
• Device Sequence Number: 16921565
• Product Code: INI
• UDI-Device Identifier: 00822383519098
• UDI-Public: 822383519098
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/12/2019
• Report Date (Section F): 07/12/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SFSCOUT4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/18/2019
• Device Age: 2 MO
• Event Location: Other
• Date Report to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2019
• 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
• Date Report Sent to FDA: 07/12/2019