MAUDE Adverse Event Report: COM-DA HEALTHCARE CO. LTD DRIVE DEVILBISS HEALTHCARE WALKER, STEEL ADULT 2 BUTTON 5'WHLS.; WALKER, MECHANICAL

Model Number	10244-1
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a walker by the end user, who reported that while using the walker, the walker hit a crack and stopped abruptly, causing her to fall over the top of the walker and sustain a fracture in the tip of her tibia.There was no specified defect in or malfunction of the device.Product labeling states,"be aware of the following, gaps in the floor." 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 DEVILBISS HEALTHCARE WALKER, STEEL ADULT 2 BUTTON 5'WHLS.
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): COM-DA HEALTHCARE CO. LTD; unit 3 no.94 dongcheng rd; dong sheng town; zhong shan city, guang dong province ; CH
• MDR Report Key: 25110559
• Report Number: 2438477-2026-00025
• Device Sequence Number: 9326872
• Product Code: ITJ
• UDI-Device Identifier: 50822383515620
• UDI-Public: (01)50822383515620
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/07/2026
• Report Date (Section F): 05/07/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 10244-1
• Device Catalogue Number: 10244-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/20/2026
• Event Location: Home
• Date Report to Manufacturer: 05/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2026
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/07/2026