MAUDE Adverse Event Report: UNKNOWN HURRYCANE

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/09/2018

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a cane.The end-user's daughter cannot confirm the model number of the cane.She believes it is a hurrycane.In an overabundance of caution we are filing "thie" report to document the incident.The end-user fainted and collapsed onto her cane.There was no defect to the cane.The patient cut her leg requiring 53 stitches.Pms is "awiting" additional "informaiton" and device retrieval.

• Brand Name: HURRYCANE
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8010225
• MDR Text Key: 125181590
• Report Number: 2438477-2018-00057
• 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: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2018
• Distributor Facility Aware Date: 09/26/2018
• Event Location: Home
• 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: 75 YR