MAUDE Adverse Event Report: UNKNOWN DRIVE DELUXE FOLDING WALKER; WALKER, MECHANICAL

Model Number	10210-4ASM
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Scar Tissue (2060); Skull Fracture (2077)
Date of Event	12/23/2025
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's daughter, who reported that the walker broke during use, causing the end user to fall resulting in broken bones in her face, with swelling and facial scarring.As part of its complaint review and evaluation process, drive devilbiss healthcare will file an update if additional information becomes available.

• Brand Name: DRIVE DELUXE FOLDING WALKER
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 24307718
• Report Number: 2438477-2026-00008
• Device Sequence Number: 18556896
• Product Code: ITJ
• UDI-Device Identifier: 50822383226205
• UDI-Public: (01)50822383226205
• 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): 02/10/2026
• Report Date (Section F): 02/10/2026

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: 10210-4ASM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/15/2026
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• 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
• Patient Weight: 93 KG
• Date Report Sent to FDA: 02/10/2026