MAUDE Adverse Event Report: DRIVE; WALKER, MECHANICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Limb Fracture (4518)

Event Date 10/02/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident allegedly involving a steerable knee walker by a letter from an attorney, which stated that the end user was using the device while exiting a building when "the front wheels was stuck at the edge, resulting in a trip and fall to the ground." the end user reportedly fell due to the wheel of the mobility device that made contact with minimal gap (alleged uneven floor) that resulted in her falling.The end user's left arm fracture required physiotherapy to help aid with recovery.The device model number and serial number is unknown.Drive devilbiss healthcare is currently investigating the incident, including attempting to inspect the device through the attorney.An update will be filed if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: WALKER, MECHANICAL
• MDR Report Key: 18773436
• MDR Text Key: 336180002
• Report Number: 2438477-2024-00010
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/23/2024

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2024
• Distributor Facility Aware Date: 01/30/2023
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other