MAUDE Adverse Event Report: CC HSING COMPANY LIMITED Drive Nitro,FirmFoam,ChampagneFrame,RTL; WALKER, MECHANICAL

Model Number	RTL10266CH-HS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Limb Fracture (4518); Blister (4537)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive medical was notified of an incident involving a rollator by the end user's daughter who reported that the wheels do not turn properly on the carpet during use, and that the rollator is too heavy and bulky for the end user to manuever, and the end user fell resulting in a broken ankle.Additionally, the brake mechanism pinches fingers causing blisters.As part of its complaint review and evaluation process, drive medical will also notify the manufacturer of the product about this complaint.

• Brand Name: Drive Nitro,FirmFoam,ChampagneFrame,RTL
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): CC HSING COMPANY LIMITED; no.1,benting; xikou township; chiayi, 62348 ; TW 62348
• MDR Report Key: 50569323
• Report Number: 2438477-2026-00059
• Device Sequence Number: 10507376
• Product Code: ITJ
• UDI-Device Identifier: 00822383549477
• UDI-Public: (01)00822383549477
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026
• Report Date (Section F): 10/02/2026

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?: Yes
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/07/2026
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 10/02/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 10/02/2026
• 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 Sex: Female
• Patient Weight: 125 LB
• Date Report Sent to FDA: 10/02/2026