MAUDE Adverse Event Report: DRIVE DEVILBISS HEALTHCARE ROLLATOR; WALKER, MECHANICAL

Model Number	R800KD-BL
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/02/2025
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.The report stated that the end user was ascending a ramp when the brakes failed to engage.As a result, the end user slipped, fell to the ground, and was transported to the emergency room where they were diagnosed with a fractured pelvis.The device was returned for evaluation.Brake functionality was tested and confirmed to operate as intended; however, inspection revealed that the wheel was significantly worn down.This wear prevented proper contact between the brake lever and the wheel surface, causing the brake to slip.Due to the wheel's condition, although the brake lever engaged, the wheel continued to slip, rendering the braking system ineffective.Drive recommends periodic visual inspection of this product by the user, to ensure that all parts and hardware are secure, that components are in good working order and not worn, torn, frayed, or loose, and that there are no obstructions or impediments to normal, safe operation.If any part or mechanism appears to be unsafe or compromised, do not use the product.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE ROLLATOR
• Common Device Name: WALKER, MECHANICAL
• MDR Report Key: 23707607
• Report Number: 2438477-2025-00068
• Device Sequence Number: 10720258
• Product Code: ITJ
• UDI-Device Identifier: 00822383004228
• UDI-Public: (01)00822383004228
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/03/2025
• Report Date (Section F): 12/03/2025

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: R800KD-BL
• Device Catalogue Number: R800KD-BL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2025
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2025
• 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
• Patient Sex: Female
• Date Report Sent to FDA: 12/03/2025