MAUDE Adverse Event Report: UNKNOWN HURRYCANE

Catalog Number FREEDOM EDITION CANE

Device Problem Fracture (1260)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 01/08/2018

Event Type  Injury  

Event Description

(b)(6) is the initial importer of the device which is a cane.We are filing this report in an over-abundance of caution due to an mdr regression analysis.The cane was discarded and is unavailable for evaluation.The base of the cane cracked while in use causing the user to fall.He received stitches.

• Brand Name: HURRYCANE
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 11060008
• MDR Text Key: 223370189
• Report Number: 2438477-2018-00093
• 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: Other
• Type of Report: Initial
• Report Date: 12/22/2020

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 Catalogue Number: FREEDOM EDITION CANE
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2020
• Distributor Facility Aware Date: 01/18/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 85