MAUDE Adverse Event Report: UNKNOWN HURRYCANE

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Concussion (2192)

Event Date 07/11/2019

Event Type  Injury  

Event Description

(b)(4) healthcare is the initial importer of the device which is a hurrycane.We do not have any specifics on the model number or serialization of the device.It was used , a hand me down from a sibling.Who no longer needed the device.He user reported that the used device broke into 3 pieces causing him to fall and suffer a major concussion, fractures bones, and become half paralyzed.The end user believes the incident caused a stroke but he has not had an mri or cat scan to confirm this.He has reported that he has seen a specialist who believes it is likely he had a stroke.

• Brand Name: HURRYCANE
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8887346
• MDR Text Key: 154161659
• Report Number: 2438477-2019-00051
• 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: 08/12/2019

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?: Yes
• 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: 08/12/2019
• Distributor Facility Aware Date: 07/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 87