MAUDE Adverse Event Report: COM-BRIDGE INTERNATIONAL CO., LTD CAREX ERGO OFFSET CANE - BLUE FLOWER

Model Number FGA58500 0000

Device Problems Collapse (1099); Unstable (1667)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 01/15/2017

Event Type  Injury  

Event Description

The end-user states that she was walking from her car to her house, and the cane collapsed.She fell on her knee, and then rolled to her hip.She had x-rays, and now the doctor states that she shattered the ball of her hip and will need surgery.She stated the lock pin was securely in place on the cane.The device is reported as having been used on grass with its rubber feet free of splits, cracks or tears.The device is reported as having used the cane for 6 months.She has two of the same cane, and is not sure which cane she fell with, as they are identical, with self-standing cane tips on both - she is having both canes returned to compass health brands just in case.

• Brand Name: CAREX ERGO OFFSET CANE - BLUE FLOWER
• Type of Device: CANE
• Manufacturer (Section D): COM-BRIDGE INTERNATIONAL CO., LTD; unit 1, no 66 yu long 3 road; dong sheng town; zhong shan city, guangdong 52841 4; CH 528414
• MDR Report Key: 6345383
• MDR Text Key: 67835150
• Report Number: 3012316249-2017-00016
• 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: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA58500 0000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2017
• Distributor Facility Aware Date: 01/27/2017
• Event Location: Other
• Date Report to Manufacturer: 02/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 98