MAUDE Adverse Event Report: COM-DA HEALTHCARE CO. LTD DRIVE DEVILBISS HEALTHCARE WALKER PLATFORM ATTACHMENT; WALKER, MECHANICAL

Model Number	10105-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	05/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a walker by a letter from an attorney, alleging the end user was using the device when the crutch attachment came off causing the end user to fall and reinjure themselves.Due to the fall, the end user required to have a revision hip surgery.Drive devilbiss healthcare is currently investigating the incident, including attempting to inspect the device.An update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE WALKER PLATFORM ATTACHMENT
• 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: 23647631
• Report Number: 2438477-2025-00065
• Device Sequence Number: 4903448
• Product Code: ITJ
• UDI-Device Identifier: 00822383109091
• UDI-Public: (01)00822383109091
• 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): 11/25/2025
• Report Date (Section F): 11/25/2025

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: 10105-1
• Device Catalogue Number: 10105-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/29/2025
• Event Location: Home
• Date Report to Manufacturer: 11/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• 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 Sex: Female
• Date Report Sent to FDA: 11/25/2025