MAUDE Adverse Event Report: CC HSING COMPANY LIMITED DRIVEMEDICAL F22 ROLLATOR, TALL, GREY; WALKER, MECHANICAL

Model Number	GV974GY-T
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	07/04/2025
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's daughter, who reported that a wheel came off during use causing the end user to fall and sustain a broken and dislocated shoulder.Drive devilbiss evaluated the rollator and confirmed the detached wheel.Upon further inspection it was discovered that the housing for the screw on the front fork was stripped, most likely due to overtightening of the screw during maintenance, therefore creating a weak bond between the screw and the front fork.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: DRIVEMEDICAL F22 ROLLATOR, TALL, GREY
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): CC HSING COMPANY LIMITED; no.1,benting, bentsuo villge; sikao township, jiayi county; chiayi, 62348 ; TW 62348
• MDR Report Key: 22665403
• Report Number: 2438477-2025-00035
• Device Sequence Number: 3702382
• Product Code: ITJ
• UDI-Device Identifier: 00822383964157
• UDI-Public: (01)00822383964157
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/30/2025
• Report Date (Section F): 07/30/2025

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: GV974GY-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/04/2025
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 07/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• 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; Other
• Patient Sex: Female
• Patient Weight: 84 KG
• Date Report Sent to FDA: 07/30/2025