MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD. DRIVE; WALKER, MECHANICAL

Model Number	R800KD-BL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an attorney letter alleging that "due to defective design, construction, and welding, the walker broke, causing our client to fall and sustain severe injuries" during use.Drive devilbiss healthcare is attempting to investigate the incident through cooperation with the end user's attorney.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO. LTD.; no. 96, zhaoyi road; dongsheng town zhongshan, guangdong 52841 4; CH 528414
• MDR Report Key: 23692693
• Report Number: 2438477-2025-00069
• Device Sequence Number: 9071885
• Product Code: ITJ
• UDI-Device Identifier: 00822383004228
• UDI-Public: (01)00822383004228
• 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): 12/02/2025
• Report Date (Section F): 12/02/2025

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/05/2025
• Event Location: Other
• Date Report to Manufacturer: 12/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2025
• 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; Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 12/02/2025