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

Model Number	RTL799
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a knee walker by the end user's mother who reported that during use, the knee rest broke in half from front to back causing the end user to fall on the toes of his pre-existing injured foot.An ultrasound was performed revealing a small blood clot although it is uncertain if this was caused by the fall.The device was returned to the original retailer and therefore is unavailable for evaluation.

• Brand Name: DRIVE ECONOMY FOLDING KNEE WALKER
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 22107578
• Report Number: 2438477-2025-00026
• Device Sequence Number: 7275722
• Product Code: ITJ
• UDI-Device Identifier: 00822383006277
• UDI-Public: (01)00822383006277
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 05/29/2025
• Report Date (Section F): 05/29/2025

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: RTL799
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/08/2025
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• 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 Age: 45 YR
• Patient Sex: Unknown
• Patient Weight: 86 KG
• Date Report Sent to FDA: 05/29/2025