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

Model Number	HCANE-BK-C2
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint involving a cane by an end user who stated, "the foot of his hurrycane came off causing him to slip and fall face first onto cement." the end went to urgent care where he received 8 stiches on his forehead.A replacement cane was sent to the end user.The hurrycane was returned to drive devilbiss for evaluation and was confirmed that the base of the hurrycane was detached.The screw that attaches the base to the cane appears to be unscrewed and loose, causing the base to be detached.The screw head had worn into the rubber base and broke surface which can cause stability issues.The hurricane that was returned reflects the design of the original hurrycane 1.0 where the base is detachable.Drive devilbiss no longer sells this version.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• 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 52840 0; CH 528400
• MDR Report Key: 18489294
• Report Number: 2438477-2024-00001
• Device Sequence Number: 6985216
• Product Code: IPS
• UDI-Device Identifier: 00822383571034
• UDI-Public: 822383571034
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2024
• Report Date (Section F): 01/10/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/18/2023
• Event Location: Home
• Date Report to Manufacturer: 01/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2024
• 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: Male
• Date Report Sent to FDA: 01/10/2024