MAUDE Adverse Event Report: UNKNOWN HURRYCANE

Model Number HURRYCANE GO CANE

Device Problem Material Twisted/Bent (2981)

Patient Problem Hip Fracture (2349)

Event Date 04/01/2018

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a cane.The cane was discarded because it was broken.No examination and root cause analysis can be performed.The cane was provided to the end-user in an assisted living facility.He fell when the cane bent.It is believed that the push button malfunctioned.He was hurt and hospitalized.The patient broke his right hip in the fall.He is 6 foot 2 inches.He requested a rollator instead of a cane replacement because he believed the cane was unsuitable for his age.

• Brand Name: HURRYCANE
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8445261
• MDR Text Key: 139607894
• Report Number: 2438477-2019-00008
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 00822383571096
• UDI-Public: 822383571096
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2019

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 GO CANE
• Device Catalogue Number: HCANE-BK-G2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2019
• Distributor Facility Aware Date: 03/05/2019
• Event Location: Nursing Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR
• Patient Weight: 90