MAUDE Adverse Event Report: FUYANG HONGWEI METAL CO. DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL

Model Number	R800KD-BL
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Wound Infection (2447)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) was notified of an incident involving a rollator by the end user who reported that the back wheels came off the device causing her to fall and hit her head.The end user sustained a black eye, bruising to face, two skin tears, and reopened a pre-existing leg wound.She was hospitalized for four days for the infected wound and received antibiotics.The device was returned for evaluation.The device shows signs of light wear.The wheels were inspected for damage and did not find any.The device was returned with no attachment knobs to adhere the wheels to frame.Product labeling states," attach the back wheels (with brake handles) by inserting tube into the rollator frame, making sure the wheels are facing the outside of the rollator.Align hole on wheel tube with frame and secure in place using the tightening knob, threading the knob on the inside.Insert c-clip above knob to secure wheel in place.".

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): FUYANG HONGWEI METAL CO.; liaoan village, wanshi town,; hangzhou city, zhejiang province ; CH
• MDR Report Key: 21159549
• Report Number: 2438477-2025-00005
• Device Sequence Number: 15361284
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2025
• Report Date (Section F): 01/15/2025

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: 01/07/2025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/30/2024
• Event Location: Home
• Date Report to Manufacturer: 01/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2025
• 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: Hospitalization
• Patient Sex: Female
• Date Report Sent to FDA: 01/15/2025