MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL DRIVE; WALKER, MECHANICAL

Model Number	796
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Bone Fracture(s) (1870)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a knee walker by the end user who reported that while in use, a wheel broke causing her to fall resulting in a bruised elbow and a fractured knee cap.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): JIANGYIN HUASHI MEDICAL; no.589, hualu road,; huashi town; jiangyin city, jiangsu province 21442 1; CH 214421
• MDR Report Key: 24627968
• Report Number: 2438477-2026-00013
• Device Sequence Number: 8698017
• Product Code: ITJ
• UDI-Device Identifier: 50822383509346
• UDI-Public: (01)50822383509346
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/18/2026
• Report Date (Section F): 03/18/2026

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: 796
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2026
• Device Age: 9 MO
• Event Location: Home
• Date Report to Manufacturer: 03/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• 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
• Date Report Sent to FDA: 03/18/2026