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

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 information has been provided at this time.

• Brand Name: HURRYWORKS
• Type of Device: CANE
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer (Section G): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 13318236
• MDR Text Key: 286424807
• Report Number: 3014644996-2022-00001
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2022

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 Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 137 KG