MAUDE Adverse Event Report: AHT ENTERPRISE CORPORATION DMI - 3-WHEEL ALUMINUM ROLLATOR W/ BASKET

Model Number	501-2014-2100
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518); Limb Pain (4836)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
User indicated the weld for the wheel assembly broke and the wheel broke off causing them to fall to the ground.The unit fell on their leg and she went to the doctor and x-rays were taken, ambulance was not required.Doctor indicated there was a fracture and released user with an ace bandage and a surgical shoe, no brace or cast applied.
Event or Problem Description
User reported - the front wheel fell off, i had the handlebars in my hand and the walker went down.My hands went down with it and my foot got fractured.

• Brand Name: DMI - 3-WHEEL ALUMINUM ROLLATOR W/ BASKET
• Common Device Name: 3-WHEEL ALUMINUM ROLLATOR W/ BASKET
• Manufacturer (Section D): AHT ENTERPRISE CORPORATION; 178 kang zhuang rd; zhoushi; kunshan, jiangsu 21530 0; CH 215300
• MDR Report Key: 25319698
• Report Number: 1000143485-2026-29078
• Device Sequence Number: 21328501
• Product Code: ITJ
• UDI-Device Identifier: 00041298003571
• UDI-Public: 041298003571
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026
• Report Date (Section F): 05/28/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 501-2014-2100
• Device Lot Number: 5391210422
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/02/2026
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 05/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2026
• 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
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Date Report Sent to FDA: 05/28/2026