MAUDE Adverse Event Report: UNKNOWN HURRYCANE

Model Number HURRYCANE FREEDOM

Device Problem Material Fragmentation (1261)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 01/08/2019

Event Type  Injury  

Event Description

Drive devilbiss is the initial importer of the device which is a hurrycane branded cane.We have not received the device for evaluation.An amended report will be tendered if the device is returned.End-user was carrying trash while using the cane.The handle broke off from the device.The end-user fell backwards hitting the left side of his face on the sidewalk.He bled from his left eyebrow.He was confused and disoriented.He went to the hospital to treat his injuries.X-rays revealed a stable break of his wrist.He received stitches for his eyebrow and pain medications for his injuries.He underwent physical therapy for his neck and wrist pain.

• Brand Name: HURRYCANE
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9484621
• MDR Text Key: 176298127
• Report Number: 2438477-2019-00083
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 50822383571060
• UDI-Public: 50822383571060
• 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: 12/17/2019

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 FREEDOM
• Device Catalogue Number: HCANE-RD-C2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2019
• Distributor Facility Aware Date: 11/07/2019
• Device Age: 2 YR
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization