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

Model Number	R800KD-RD
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Head Injury (1879); Coma (2417)
Date of Event	12/21/2024
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 son who reported that the front left wheel fell off causing the end user to fall and hit their head.The end user sustained a head injury that required surgery and is currently in a coma.The end user's son is not releasing the device at this time.The user's manual instructs the user to be sure that both knobs are fully tightened and are at equal heights and to test rollator for stability before applying full weight to hand grips.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.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
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): FUYANG HONGWEI METAL CO.; liaoan village, wanshi town,; hangzhou city, zhejiang province ; CH
• MDR Report Key: 21159551
• Report Number: 2438477-2025-00004
• Device Sequence Number: 7631087
• Product Code: ITJ
• UDI-Device Identifier: 00822383004235
• UDI-Public: (01)00822383004235
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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-RD
• Device Catalogue Number: R800KD-RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/23/2024
• 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; Other
• Patient Age: 78 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/15/2025