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

Model Number	R800KD-RD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's daughter who stated that the end user was sitting on the device and swung her leg out to the right and her leg was cut by something on the device.The end user required stitches, and a tetanus shot.The end users' daughter did not know what part of the device cut the end user's leg.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,; fuyang district; hangzhou city, zhejiang province ; CH
• MDR Report Key: 20567834
• Report Number: 2438477-2024-00055
• Device Sequence Number: 18007114
• Product Code: ITJ
• UDI-Device Identifier: 00822383004235
• UDI-Public: 00822383004235
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/30/2024
• Report Date (Section F): 10/30/2024

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?: No
• 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: 09/30/2024
• Event Location: Home
• Date Report to Manufacturer: 11/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2024
• 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: 10/30/2024