MAUDE Adverse Event Report: HURRYCANE

Model Number HCANE-BK-C2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

Drive devilbiss healthcare received a complaint regarding a broken hurrycane.Enduser was leaving her house and the top of the cane (handle) broke causing her to fall.Enduser suffered fractured pinky and hemorrhaged out of her nose.This report is based on information provided by the enduser's son.Product was evaluated and the claimed broken handle could not be confirmed.Device is fully functional.

• Brand Name: HURRYCANE
• Type of Device: CANE
• MDR Report Key: 5795147
• MDR Text Key: 49561190
• Report Number: 2438477-2016-00031
• 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: 07/15/2016,06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HCANE-BK-C2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2016
• Distributor Facility Aware Date: 06/15/2016
• Device Age: 1 MO
• 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): Hospitalization
• Patient Age: 91 YR