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

Model Number HCANE-BK-C2

Device Problem Material Fragmentation (1261)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 08/18/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 332602519
• Report Number: 2438477-2024-00001
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 00822383571034
• UDI-Public: 822383571034
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 01/10/2024
• Distributor Facility Aware Date: 08/18/2023
• Event Location: Home
• Date Report to Manufacturer: 01/10/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male