MAUDE Adverse Event Report: DRIVE; CANE

Model Number 731-840

Device Problem Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 11/04/2022

Event Type  malfunction  

Event Description

Drive devilbiss healthcare was notified of an incident involving a cane by an end user, who reported that who reported that the cane collapsed, causing him to fall and hurt his shoulder and required physical therapy treatments.Drive did not get the product back for evaluation.

• Brand Name: DRIVE
• Type of Device: CANE
• MDR Report Key: 15447683
• MDR Text Key: 300164567
• Report Number: 2438477-2022-00087
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 07540212101902
• UDI-Public: 07540212101902
• 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: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 731-840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2022
• Distributor Facility Aware Date: 12/03/2021
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male