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

Model Number	TITANAXS-22CS
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	Wound Infection (2447)
Type of Reportable Event	Serious Injury
Event or Problem Description
Devilbiss healthcare was notified through claims of a complaint involving a powered wheelchair.The end user's attorney stated that the "footrest became loose and [the end user] suffered a cut on his toe from the screw which led to an infection and subsequently that toe had to be amputated." there were no additional details as to what type of medical treatment was sought within the initial complaint.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): WU'S TECH CO., LTD.; yuan peir st. no. 225; hsin-chu city, hsin-chu 30093 ; TW 30093
• Manufacturer (Section G): WU'S TECH CO., LTD.; yuan peir st. no. 225; hsin-chu city, hsin-chu 30093 ; TW 30093
• Manufacturer Contact: tim kao ; yuan peir st. no. 225; hsin-chu city, hsin-chu 30093 ; TW 30093
• MDR Report Key: 17386555
• Report Number: 9616873-2023-00005
• Device Sequence Number: 12280081
• Product Code: ITI
• UDI-Device Identifier: 00822383933924
• UDI-Public: 822383933924
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

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: TITANAXS-22CS
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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; Hospitalization
• Patient Sex: Male