MAUDE Adverse Event Report: COM-DA HEALTHCARE CO. LTD DRIVE DEVILBISS QUAD CANE

Model Number	146-10301F-4
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a quad cane by a provider who reported that the cane broke while in use causing the end-user to fall to the ground and fracture their shoulder.The device was returned for evaluation.Upon evaluation, it was observed that the cane shaft tube was broken by the detent buttonhole.There were no other visible defects identified to the device that may have led to the reported malfunction.The manufacturer will also be notified of this incident.

• Brand Name: DRIVE DEVILBISS QUAD CANE
• Common Device Name: CANE
• 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: 21653765
• Report Number: 2438477-2025-00017
• Device Sequence Number: 15772067
• Product Code: IPS
• UDI-Device Identifier: 00612479222694
• UDI-Public: (01)00612479222694
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/20/2025
• Report Date (Section F): 03/20/2025

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: 146-10301F-4
• Device Catalogue Number: 146-10301F-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/21/2025
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 03/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• 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: Other
• Patient Sex: Male
• Date Report Sent to FDA: 03/20/2025