MAUDE Adverse Event Report: WU'S TECH CO., LTD. DRIVEMEDICAL; WHEELCHAIR, POWERED

Model Number	TITANLTE-18FS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a power wheelchair by the end user who stated she was getting off the power chair when the foot plate "snapped up" and cut her right shin.She received eight stitches at the er.As part of the complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVEMEDICAL
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): WU'S TECH CO., LTD.; no. 225, yuan peir st.; hsin-chu city, hsinchu 30093 ; TW 30093
• MDR Report Key: 21091801
• Report Number: 2438477-2025-00001
• Device Sequence Number: 15739638
• Product Code: ITI
• UDI-Device Identifier: 00822383973838
• UDI-Public: (01)00822383973838
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2025
• Report Date (Section F): 01/07/2025

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: TITANLTE-18FS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/10/2024
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 01/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2025
• 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; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/07/2025