MAUDE Adverse Event Report: UNKNOWN HURRYCANE

Model Number	HURRYCANE FREEDOM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Laceration(s) (1946)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9484621
• Report Number: 2438477-2019-00083
• Device Sequence Number: 16201865
• Product Code: IPS
• UDI-Device Identifier: 50822383571060
• UDI-Public: 50822383571060
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2019
• Report Date (Section F): 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
• Operator of Device: 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
• Distributor Facility Aware Date: 11/07/2019
• Device Age: 2 YR
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Date Report Sent to FDA: 12/17/2019