MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD WALMART FOLDING KNEE WALKER; WALKER, MECHANICAL

Model Number	EQKW200
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	03/12/2025
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 spouse, who stated that the knob that secures the handlebar height is too short and that it came out of the handlebar while she was using it causing her to lose control of the steering.The end user fell and tore ligaments in her left ankle.A review of the complaint history for this product reveals no other complaints and this appears to be an isolated event.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: WALMART FOLDING KNEE WALKER
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD; no. 589 hualu road; huashi town; jiangyin city jiangsu, 21442 1; CH 214421
• MDR Report Key: 21899374
• Report Number: 2438477-2025-00022
• Device Sequence Number: 21038098
• Product Code: ITJ
• UDI-Device Identifier: 00681131408592
• UDI-Public: (01)00681131408592
• 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): 04/24/2025
• Report Date (Section F): 04/24/2025

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: EQKW200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/02/2025
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 04/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2025
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Date Report Sent to FDA: 04/24/2025