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

Model Number	HCANE-BK-C2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a cane branded hurryworks.We have not received the device for evaluation.We are filing this report in an overabundance of caution.We will submit a followup when new data becomes available.The top of the cane snapped off and exposed metal and screw while the user was walking in the kitchen.He is six foot two inches tall.The broken cane reportedly punctured his shoulder causing bleeding and his knees folded backwards.He advised that he can barely walk at all now.He is looking for compensation.No additional informaiton has been provided at this time.

• Brand Name: HURRYWORKS
• Common Device Name: CANE
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; unit 3 no.94 dongcheng road; dong sheng town; zhong shan city, guangdong ; CH
• MDR Report Key: 12085717
• Report Number: 2438477-2021-00027
• Device Sequence Number: 16981417
• Product Code: IPS
• UDI-Device Identifier: 00822383571034
• UDI-Public: 822383571034
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2021
• Report Date (Section F): 06/29/2021

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 the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/14/2021
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2021
• 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: 41 YR
• Patient Weight: 137
• Date Report Sent to FDA: 06/29/2021