MAUDE Adverse Event Report: DRIVE; CANE

Model Number	731-840
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Fall (1848)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CANE
• MDR Report Key: 15447683
• Report Number: 2438477-2022-00087
• Device Sequence Number: 12690092
• Product Code: IPS
• UDI-Device Identifier: 07540212101902
• UDI-Public: 07540212101902
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2022
• Report Date (Section F): 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
• Distributor Facility Aware Date: 12/03/2021
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 09/19/2022