MAUDE Adverse Event Report: UNKNOWN HURRYCANE

Model Number UNKNOWN

Device Problem Detachment Of Device Component (1104)

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

Event Date 01/18/2017

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of this device.Drive was notified of the event by an attorney letter.We have minimal information regarding the event and outcome.Our post market surveillance associate is continuing to reach out for additional information as per their process.One of the feet on the bottom of the base of the cane came off while in use.The enduser fell and broke bones.The cane is branded hurrycane and has a bed bath & beyond sku of (b)(4).We await feedback from the lawyer with specifics.

• Brand Name: HURRYCANE
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 6725987
• MDR Text Key: 80493244
• Report Number: 2438477-2017-00061
• 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: Attorney
• Type of Report: Initial
• Report Date: 07/19/2017,06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2017
• Distributor Facility Aware Date: 06/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other