MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD. DRIVE DEVILBISS HEALTHCARE CLEVER-LITE WALKER; WALKER, MECHANICAL

Model Number	10243
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Swelling/ Edema (4577)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a walker by the end user who reported the front wheel broke off while in use causing the end user to fall onto her left side and hit her head.The end user had testing completed at the hospital that showed bruising and inflammation to her left arm and leg and was prescribed pain medication, oral antibiotics and anti-inflammatory medication.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 CLEVER-LITE WALKER
• 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: 23647630
• Report Number: 2438477-2025-00067
• Device Sequence Number: 14678339
• Product Code: ITJ
• UDI-Device Identifier: 00822383138107
• UDI-Public: (01)00822383138107
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/25/2025
• Report Date (Section F): 11/25/2025

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: 10243
• Device Catalogue Number: 10243
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/29/2025
• Event Location: Home
• Date Report to Manufacturer: 11/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• 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: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 11/25/2025