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

Model Number HCANE-BK-C2

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 05/08/2021

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 262617775
• Report Number: 2438477-2021-00027
• 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: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: HCANE-BK-C2
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2021
• Distributor Facility Aware Date: 05/14/2021
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 07/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 137