MAUDE Adverse Event Report: UNKNOWN DRIVE; WALKER, MECHANICAL

Model Number	R726BL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Tooth Fracture (2428)
Date of Event	01/13/2026
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 daughter, who reported that the rollator leg broke while the end user was sitting on the seat, causing her to fall and hit her head resulting in a chipped tooth as well as pain in her right knee and foot.As part of its complaint review and evaluation process, 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: 24280293
• Report Number: 2438477-2026-00006
• Device Sequence Number: 21322900
• Product Code: ITJ
• UDI-Device Identifier: 00822383233208
• UDI-Public: (01)00822383233208
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 02/06/2026
• Report Date (Section F): 02/06/2026

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: 01/15/2026
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2026
• 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: Required Intervention; Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Date Report Sent to FDA: 02/06/2026