MAUDE Adverse Event Report: UNKNOWN HURRYCANE

Model Number HCANE-S7

Device Problem Detachment Of Device Component (1104)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/26/2016

Event Type  Injury  

Event Description

(b)(6) received notice about this incident from the end user's son, involving a cane, a product imported and distributed by (b)(6).According to the end user's son, his mother was using the cane in the bathroom when the handle of the cane allegedly snapped off causing her to fall.She was taken to the er and it was determined that she broke her left ankle and right wrist.This report is based on the information that was provided by the end user's son.

• Brand Name: HURRYCANE
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5770182
• MDR Text Key: 48813311
• Report Number: 2438477-2016-00030
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 07/06/2016,04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HCANE-S7
• 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: 07/06/2016
• Distributor Facility Aware Date: 06/06/2016
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention