MAUDE Adverse Event Report: A & I INDUSTRIES LTD DRIVE; WALKER, MECHANICAL

Model Number	RTL10266CH-HS
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by the end user, who stated that a wheel on the rollator bent while in use causing her to fall and break her left ankle and tibia.The end user is not returning the device for evaluation.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): A & I INDUSTRIES LTD; lian du industry park; le liu town, shunde district; foshan city, guangdong ; CH
• MDR Report Key: 21459788
• Report Number: 2438477-2025-00013
• Device Sequence Number: 15501050
• Product Code: ITJ
• UDI-Device Identifier: 00822383549477
• UDI-Public: (01)00822383549477
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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): 02/25/2025
• Report Date (Section F): 02/25/2025

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: RTL10266CH-HS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/03/2025
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 02/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2025
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Date Report Sent to FDA: 02/25/2025