MAUDE Adverse Event Report: UNKNOWN DRIVE; WALKER, MECHANICAL

Model Number	R726BL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by the end user's spouse who reported that while in use, a weld and front fork broke causing her to fall and break her foot.The end user's spouse repaired the weld and is refusing to return the rollator.The end user's spouse was advised against the use of the home-repaired rollator.Drive devilbiss healthcare will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 24639922
• Report Number: 2438477-2026-00014
• Device Sequence Number: 21349681
• Product Code: ITJ
• UDI-Device Identifier: 00822383233208
• UDI-Public: (01)00822383233208
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2026
• Report Date (Section F): 03/19/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: R726BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/25/2026
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 03/19/2026