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

Model Number	TITANLTE-18FS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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 WHEELCHAIR, POWERED
• 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
• Manufacturer (Section G): WU'S TECH CO., LTD.; no.225, yuan peir st.; hsin-chu city, hsinchu 30093 ; TW 30093
• Manufacturer Contact: tim kao ; no.225, yuan peir st.; hsin-chu city, hsinchu 30093 ; TW 30093
• MDR Report Key: 21280348
• Report Number: 3007963811-2025-00001
• Device Sequence Number: 9355645
• Product Code: ITI
• UDI-Device Identifier: 00822383973838
• UDI-Public: (01)00822383973838
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female