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 Code	Concussion (2192)
Date of Event	11/15/2024
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 who stated that the device collapsed while in use, causing her to fall and hit her head, which resulted in a concussion.This was the second reported collapse; the first one did not result in any incident or injury.It is unclear whether the end user was properly locking the rollator prior to use.As part of the 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,; fuyang district; hangzhou city, zhejiang province ; CH
• MDR Report Key: 20846094
• Report Number: 2438477-2024-00059
• Device Sequence Number: 8255975
• Product Code: ITJ
• UDI-Device Identifier: 00822383004235
• UDI-Public: (01)00822383004235
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/04/2024
• Report Date (Section F): 12/04/2024

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: 11/15/2024
• Event Location: Home
• Date Report to Manufacturer: 12/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• 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: 12/04/2024