MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD HURRYCANE

Model Number HURRYCANE

Device Problem Use of Device Problem (1670)

Patient Problem Limb Fracture (4518)

Event Date 09/04/2021

Event Type  Injury  

Event Description

From (b)(6): (b)(6) healthcare is the initial importer of the device which is a hurrycane.The device has not be returned for evaluation.We are filing this report in an overabundance of caution.We will submit a follow-up when additional data becomes available.The end-user attempted to rise out of a chair using his cane.He did not notice that the cane was not fully extended.When he put his weight on the cane, he fell and broke his right arm and aggravated an old back injury.But at the ct scan for his back they didn't see any issues bone related.He was told it was solely a muscle injury probably related to an old back injury.

• Brand Name: HURRYCANE
• 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: 13650177
• MDR Text Key: 290448269
• Report Number: 3014644996-2022-00009
• Device Sequence Number: 1
• Product Code: IPS
• 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: 03/02/2022

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: HURRYCANE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 80 KG