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
Per distributor mdr # 2438477-2025-00025: 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; district, no. 6 workshop ii; zhongshan city, guangdong 52840 0; CH 528400
• Manufacturer (Section G): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong 52840 0; CH 528400
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7202545756
• MDR Report Key: 22082061
• Report Number: 3014644996-2025-00002
• Device Sequence Number: 6947474
• 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: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: HCANE-BK-C2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown