MAUDE Adverse Event Report: UNKNOWN HURRYCANE

Model Number HURRYCANE

Device Problem Use of Device Problem (1670)

Patient Problem Limb Fracture (4518)

Event Date 09/04/2021

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a hurrycane.The device has not be returned for evaluation.We are filing this report in an overabundance of caution.We will submit a follow-up when additional data becomes available.The end-user attempted to rise out of a chair using his cane.He did not notice that the cane was not fully extended.When he put his weight on the cane, he fell and broke his right arm and aggravated an old back injury.But at the ct scan for his back they didn't see any issues bone related.He was told it was solely a muscle injury probably related to an old back injury.

• Brand Name: HURRYCANE
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12497224
• MDR Text Key: 272214560
• Report Number: 2438477-2021-00046
• Device Sequence Number: 1
• Product Code: IPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 09/20/2021

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2021
• Distributor Facility Aware Date: 09/15/2021
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2021
• 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: 60 YR
• Patient Weight: 80