MAUDE Adverse Event Report: NINGO LIMING METAL PRODUCTS CO. HURRYCANE; WALKING CANE

Model Number 04297-3-R

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 01/16/2014

Event Type  Injury  

Event Description

Customer reported she fell and broke her leg in 2 places and alleges that the cane collapsed which caused her fall.It is unk if there were any witnesses.

• Brand Name: HURRYCANE
• Type of Device: WALKING CANE
• Manufacturer (Section D): NINGO LIMING METAL PRODUCTS CO.
• MDR Report Key: 4575259
• MDR Text Key: 20364962
• Report Number: 3009198231-2014-00002
• Device Sequence Number: 1
• Product Code: KHY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 04297-3-R
• Device Lot Number: 1140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/02/2014
• Device Age: 6 MO
• Event Location: Other
• Date Report to Manufacturer: 06/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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: 92 YR