MAUDE Adverse Event Report: UNKNOWN HURRYCANE

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 04/28/2018

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a hurrycane branded cane.Drive became aware of the incident through a legal summons withdrawing permission to obtain medical records or statements for our investigation.We are filing this report in an overabundance of caution.Our claims department will provide required data sets as they become available.The end-user sustained injuries from a slip and fall incident while using a cane reportedly branded hurrycane.The cane handle reportedly snapped.She fell and fractured her ankle resulting in surgery.

• Brand Name: HURRYCANE
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8301898
• MDR Text Key: 134895732
• Report Number: 2438477-2018-00056
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/12/2018

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: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2018
• Distributor Facility Aware Date: 09/28/2018
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention