MAUDE Adverse Event Report: COM-DA HEALTHCARE CO. LTD DRIVE HURRYCANE® FREEDOM EDITION¿

Model Number	HCANE-BK-C2
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Laceration(s) (1946); Concussion (2192)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a cane by the end user who reported that the base of the cane will not stay screwed into frame of the cane despite her repeated attempts to tighten the base.The end user took a step forward and the cane wobbled causing her to fall backwards and hit her head.She received three staples and a concussion from the fall.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 HURRYCANE® FREEDOM EDITION¿
• Common Device Name: CANE
• Manufacturer (Section D): COM-DA HEALTHCARE CO. LTD; no. 1, jinzhao street, west di; no. 6 workshop ii; zhong shan city, guang dong province 52840 0; CH 528400
• MDR Report Key: 22078342
• Report Number: 2438477-2025-00025
• Device Sequence Number: 15793496
• Product Code: IPS
• UDI-Device Identifier: 00822383571034
• UDI-Public: (01)00822383571034
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/23/2025
• Report Date (Section F): 05/23/2025

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: HCANE-BK-C2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/05/2025
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 05/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2025
• 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 Age: 67 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/23/2025